Medical device manufacturer
Linvatec Corp. dba ConMed Linvatec
Linvatec Corp. dba ConMed Linvatec holds 97 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 88 days. openFDA lists 117 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 97
- Product codes
- 23
- Median review
- 88 days
- Recall records
- 117
How does FDA spell Linvatec Corp. dba ConMed Linvatec?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Linvatec Corp DBA Linvatec/Hal | device/recall | normalised |
| Linvatec Corp. | device/recall | normalised |
| Linvatec Corp. | device/510k | normalised |
| Linvatec Corp. dba ConMed Linvatec | device/enforcement | normalised |
| Linvatec Corp. dba ConMed Linvatec | device/recall | normalised |
| Linvatec Corporation | device/registrationlisting | normalised |
| Linvatec Corporation D/B/A Conmed Linvatec | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Linvatec Corp. dba ConMed Linvatec file in?
23 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HRX | Arthroscope | 19 | 111 days | |
| HWC | Screw, Fixation, Bone | 17 | 160 days | |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 12 | 83 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 12 | 75 days | |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 110 days | |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 5 | 65 days | |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 24 days | |
| HBC | Motor, Drill, Electric | 3 | 52 days | |
| JOS | Electrode, Electrosurgical | 3 | 86 days | |
| DZI | Drill, Bone, Powered | 2 | 68 days | |
| GEY | Motor, Surgical Instrument, Ac-Powered | 2 | 77 days | |
| FHO | Pneumoperitoneum Needle | 1 | 30 days | |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 55 days | |
| GDW | Staple, Implantable | 1 | 161 days | |
| HAB | Saw, Powered, And Accessories | 1 | 88 days | |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 206 days | |
| HIG | Insufflator, Hysteroscopic | 1 | 507 days | |
| HIH | Hysteroscope (And Accessories) | 1 | 754 days | |
| HTN | Washer, Bolt Nut | 1 | 121 days | |
| HTY | Pin, Fixation, Smooth | 1 | 71 days | |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 19 days | |
| JDR | Staple, Fixation, Bone | 1 | 247 days | |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 142 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Linvatec Corp. dba ConMed Linvatec had a recall?
openFDA lists 117 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1680-2013Class IITerminatedHRX
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.
Z-1681-2013Class IITerminatedHRX
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.
Z-1340-2013Class IITerminatedKQM
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.
Z-1619-2013Class IITerminatedMAI
Incorrect blue/white suture was used.
Z-0916-2013Class IIITerminatedGEY
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.
Showing the 5 most recently initiated of 117.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Linvatec Corp. dba ConMed Linvatec cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K131035 | Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM | MBI | 81 | |
| K130497 | D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION | HBC | 31 | |
| K121890 | GENESYS PRESSFT SUTURE ANCHOR | MAI | 55 | |
| K112965 | NANO SUTURE ANCHOR | MBI | 28 | |
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | MBI | 86 | |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | MBI | 27 | |
| K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | MAI | 87 | |
| K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | MAI | 74 | |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | GEI | 110 | |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | HRX | 105 |
Source: openFDA device/510k · retrieved
Where is Linvatec Corp. dba ConMed Linvatec registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Linvatec Corp. dba ConMed Linvatec files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.