{
  "companyId": "50423",
  "slug": "linvatec-corp-dba-conmed-linvatec-50423",
  "name": "Linvatec Corp. dba ConMed Linvatec",
  "clearances": {
    "total": 97,
    "last12Months": 0,
    "first": "1992-08-06",
    "latest": "2013-07-02"
  },
  "medianReviewDays": 88,
  "productCodeCount": 23,
  "recalls": {
    "total": 117,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1680-2013",
        "productCode": "HRX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-05-30",
        "reason": "Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site."
      },
      {
        "resNumber": "Z-1681-2013",
        "productCode": "HRX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-05-30",
        "reason": "Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site."
      },
      {
        "resNumber": "Z-1340-2013",
        "productCode": "KQM",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-03-18",
        "reason": "The VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue."
      },
      {
        "resNumber": "Z-1619-2013",
        "productCode": "MAI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2013-03-06",
        "reason": "Incorrect blue/white suture was used."
      },
      {
        "resNumber": "Z-0916-2013",
        "productCode": "GEY",
        "status": "Terminated",
        "recallClass": "Class III",
        "initiated": "2013-01-24",
        "reason": "The Membrane Switch Panel (referred to as \"front panel\" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "HRX",
      "deviceName": "Arthroscope",
      "clearances": 19,
      "latest": "2006-05-11",
      "medianReviewDays": 111
    },
    {
      "code": "HWC",
      "deviceName": "Screw, Fixation, Bone",
      "clearances": 17,
      "latest": "2005-03-25",
      "medianReviewDays": 160
    },
    {
      "code": "MAI",
      "deviceName": "Fastener, Fixation, Biodegradable, Soft Tissue",
      "clearances": 12,
      "latest": "2012-08-22",
      "medianReviewDays": 83
    },
    {
      "code": "MBI",
      "deviceName": "Fastener, Fixation, Nondegradable, Soft Tissue",
      "clearances": 12,
      "latest": "2013-07-02",
      "medianReviewDays": 75
    },
    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
      "clearances": 6,
      "latest": "2009-02-25",
      "medianReviewDays": 110
    },
    {
      "code": "ERL",
      "deviceName": "Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece",
      "clearances": 5,
      "latest": "1998-07-20",
      "medianReviewDays": 65
    },
    {
      "code": "GCJ",
      "deviceName": "Laparoscope, General & Plastic Surgery",
      "clearances": 4,
      "latest": "2003-06-04",
      "medianReviewDays": 24
    },
    {
      "code": "HBC",
      "deviceName": "Motor, Drill, Electric",
      "clearances": 3,
      "latest": "2013-03-29",
      "medianReviewDays": 52
    },
    {
      "code": "JOS",
      "deviceName": "Electrode, Electrosurgical",
      "clearances": 3,
      "latest": "2000-02-10",
      "medianReviewDays": 86
    },
    {
      "code": "DZI",
      "deviceName": "Drill, Bone, Powered",
      "clearances": 2,
      "latest": "2006-04-10",
      "medianReviewDays": 68
    },
    {
      "code": "GEY",
      "deviceName": "Motor, Surgical Instrument, Ac-Powered",
      "clearances": 2,
      "latest": "2005-05-17",
      "medianReviewDays": 77
    },
    {
      "code": "FHO",
      "deviceName": "Pneumoperitoneum Needle",
      "clearances": 1,
      "latest": "1994-06-24",
      "medianReviewDays": 30
    },
    {
      "code": "GCT",
      "deviceName": "Light Source, Endoscope, Xenon Arc",
      "clearances": 1,
      "latest": "2003-08-21",
      "medianReviewDays": 55
    },
    {
      "code": "GDW",
      "deviceName": "Staple, Implantable",
      "clearances": 1,
      "latest": "1992-08-06",
      "medianReviewDays": 161
    },
    {
      "code": "HAB",
      "deviceName": "Saw, Powered, And Accessories",
      "clearances": 1,
      "latest": "2001-10-19",
      "medianReviewDays": 88
    },
    {
      "code": "HET",
      "deviceName": "Laparoscope, Gynecologic (And Accessories)",
      "clearances": 1,
      "latest": "1994-12-15",
      "medianReviewDays": 206
    },
    {
      "code": "HIG",
      "deviceName": "Insufflator, Hysteroscopic",
      "clearances": 1,
      "latest": "1994-12-29",
      "medianReviewDays": 507
    },
    {
      "code": "HIH",
      "deviceName": "Hysteroscope (And Accessories)",
      "clearances": 1,
      "latest": "1994-06-14",
      "medianReviewDays": 754
    },
    {
      "code": "HTN",
      "deviceName": "Washer, Bolt Nut",
      "clearances": 1,
      "latest": "1996-02-09",
      "medianReviewDays": 121
    },
    {
      "code": "HTY",
      "deviceName": "Pin, Fixation, Smooth",
      "clearances": 1,
      "latest": "2005-01-19",
      "medianReviewDays": 71
    },
    {
      "code": "HWE",
      "deviceName": "Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment",
      "clearances": 1,
      "latest": "1996-03-20",
      "medianReviewDays": 19
    },
    {
      "code": "JDR",
      "deviceName": "Staple, Fixation, Bone",
      "clearances": 1,
      "latest": "1993-06-04",
      "medianReviewDays": 247
    },
    {
      "code": "LXH",
      "deviceName": "Orthopedic Manual Surgical Instrument",
      "clearances": 1,
      "latest": "1994-08-26",
      "medianReviewDays": 142
    }
  ],
  "productCodesShown": 23,
  "productCodesTotal": "23",
  "recentClearances": [
    {
      "kNumber": "K131035",
      "deviceName": "Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM",
      "productCode": "MBI",
      "decisionDate": "2013-07-02",
      "reviewDays": 81
    },
    {
      "kNumber": "K130497",
      "deviceName": "D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION",
      "productCode": "HBC",
      "decisionDate": "2013-03-29",
      "reviewDays": 31
    },
    {
      "kNumber": "K121890",
      "deviceName": "GENESYS PRESSFT SUTURE ANCHOR",
      "productCode": "MAI",
      "decisionDate": "2012-08-22",
      "reviewDays": 55
    },
    {
      "kNumber": "K112965",
      "deviceName": "NANO SUTURE ANCHOR",
      "productCode": "MBI",
      "decisionDate": "2011-11-02",
      "reviewDays": 28
    },
    {
      "kNumber": "K092998",
      "deviceName": "CONMED LINVATEC INTERCEPT IMPLANT",
      "productCode": "MBI",
      "decisionDate": "2009-12-23",
      "reviewDays": 86
    },
    {
      "kNumber": "K091549",
      "deviceName": "CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM",
      "productCode": "MBI",
      "decisionDate": "2009-06-23",
      "reviewDays": 27
    },
    {
      "kNumber": "K090835",
      "deviceName": "CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR",
      "productCode": "MAI",
      "decisionDate": "2009-06-22",
      "reviewDays": 87
    },
    {
      "kNumber": "K090186",
      "deviceName": "CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES",
      "productCode": "MAI",
      "decisionDate": "2009-04-10",
      "reviewDays": 74
    },
    {
      "kNumber": "K083281",
      "deviceName": "EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-",
      "productCode": "GEI",
      "decisionDate": "2009-02-25",
      "reviewDays": 110
    },
    {
      "kNumber": "K060198",
      "deviceName": "MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW",
      "productCode": "HRX",
      "decisionDate": "2006-05-11",
      "reviewDays": 105
    }
  ],
  "nameVariants": {
    "total": "7",
    "shown": [
      {
        "name": "Linvatec Corp DBA Linvatec/Hal",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Linvatec Corp.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Linvatec Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Linvatec Corp. dba ConMed Linvatec",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Linvatec Corp. dba ConMed Linvatec",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Linvatec Corporation",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Linvatec Corporation D/B/A Conmed Linvatec",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Linvatec%20Corp.%20dba%20ConMed%20Linvatec%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Linvatec%20Corp.%20dba%20ConMed%20Linvatec%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.047Z"
}