{ "companyId": "60606", "slug": "medos-international-sarl-60606", "name": "Medos International Sarl", "clearances": { "total": 101, "last12Months": 3, "first": "2010-08-31", "latest": "2026-05-26" }, "medianReviewDays": 90, "productCodeCount": 25, "recalls": { "total": 1, "openLast12Months": 0, "recent": [ { "resNumber": "Z-1284-2024", "productCode": "QJP", "status": "Open, Classified", "recallClass": "Class I", "initiated": "2024-02-02", "reason": "Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism." } ] }, "registration": { "sites": 1, "countries": [ "US" ] }, "productCodes": [ { "code": "NKB", "deviceName": "Thoracolumbosacral Pedicle Screw System", "clearances": 16, "latest": "2025-10-21", "medianReviewDays": 69 }, { "code": "MAX", "deviceName": "Intervertebral Fusion Device With Bone Graft, Lumbar", "clearances": 12, "latest": "2023-03-08", "medianReviewDays": 89 }, { "code": "OLO", "deviceName": "Orthopedic Stereotaxic Instrument", "clearances": 12, "latest": "2026-05-26", "medianReviewDays": 126 }, { "code": "MBI", "deviceName": "Fastener, Fixation, Nondegradable, Soft Tissue", "clearances": 11, "latest": "2023-10-06", "medianReviewDays": 59 }, { "code": "MAI", "deviceName": "Fastener, Fixation, Biodegradable, Soft Tissue", "clearances": 8, "latest": "2019-08-22", "medianReviewDays": 105 }, { "code": "NKG", "deviceName": "Posterior Cervical Screw System", "clearances": 6, "latest": "2023-11-09", "medianReviewDays": 85 }, { "code": "GAT", "deviceName": "Suture, Nonabsorbable, Synthetic, Polyethylene", "clearances": 5, "latest": "2022-04-26", "medianReviewDays": 127 }, { "code": "JXG", "deviceName": "Shunt, Central Nervous System And Components", "clearances": 4, "latest": "2015-10-27", "medianReviewDays": 82 }, { "code": "KWQ", "deviceName": "Appliance, Fixation, Spinal Intervertebral Body", "clearances": 4, "latest": "2017-07-20", "medianReviewDays": 63 }, { "code": "HRX", "deviceName": "Arthroscope", "clearances": 3, "latest": "2022-10-18", "medianReviewDays": 266 }, { "code": "PDQ", "deviceName": "Neurosurgical Nerve Locator", "clearances": 3, "latest": "2023-02-10", "medianReviewDays": 142 }, { "code": "GEI", "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories", "clearances": 2, "latest": "2016-12-01", "medianReviewDays": 24 }, { "code": "HCG", "deviceName": "Device, Neurovascular Embolization", "clearances": 2, "latest": "2022-07-14", "medianReviewDays": 25 }, { "code": "KRA", "deviceName": "Catheter, Continuous Flush", "clearances": 2, "latest": "2022-04-12", "medianReviewDays": 111 }, { "code": "GWM", "deviceName": "Device, Monitoring, Intracranial Pressure", "clearances": 1, "latest": "2016-01-22", "medianReviewDays": 127 }, { "code": "KWP", "deviceName": "Appliance, Fixation, Spinal Interlaminal", "clearances": 1, "latest": "2013-08-22", "medianReviewDays": 27 }, { "code": "LXT", "deviceName": "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite", "clearances": 1, "latest": "2011-10-31", "medianReviewDays": 77 }, { "code": "MQP", "deviceName": "Spinal Vertebral Body Replacement Device", "clearances": 1, "latest": "2018-06-11", "medianReviewDays": 179 }, { "code": "MRW", "deviceName": "System, Facet Screw Spinal Device", "clearances": 1, "latest": "2019-11-20", "medianReviewDays": 90 }, { "code": "NDN", "deviceName": "Cement, Bone, Vertebroplasty", "clearances": 1, "latest": "2011-12-22", "medianReviewDays": 80 }, { "code": "ODP", "deviceName": "Intervertebral Fusion Device With Bone Graft, Cervical", "clearances": 1, "latest": "2012-04-26", "medianReviewDays": 65 }, { "code": "PGM", "deviceName": "Growing Rod System", "clearances": 1, "latest": "2019-09-24", "medianReviewDays": 141 }, { "code": "PLR", "deviceName": "Spinal Vertebral Body Replacement Device - Cervical", "clearances": 1, "latest": "2019-12-20", "medianReviewDays": 312 }, { "code": "PML", "deviceName": "Bone Cement, Posterior Screw Augmentation", "clearances": 1, "latest": "2016-12-20", "medianReviewDays": 265 }, { "code": "QJP", "deviceName": "Catheter, Percutaneous, Neurovasculature", "clearances": 1, "latest": "2020-02-27", "medianReviewDays": 149 } ], "productCodesShown": 25, "productCodesTotal": "25", "recentClearances": [ { "kNumber": "K254157", "deviceName": "CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody", "productCode": "OLO", "decisionDate": "2026-05-26", "reviewDays": 155 }, { "kNumber": "K260240", "deviceName": "SYMPHONY Navigation Ready Instruments", "productCode": "OLO", "decisionDate": "2026-03-27", "reviewDays": 60 }, { "kNumber": "K253249", "deviceName": "TriALTIS™ Spine System", "productCode": "NKB", "decisionDate": "2025-10-21", "reviewDays": 22 }, { "kNumber": "K243249", "deviceName": "TriALTIS™ Spine System", "productCode": "NKB", "decisionDate": "2025-01-17", "reviewDays": 98 }, { "kNumber": "K241893", "deviceName": "CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays", "productCode": "OLO", "decisionDate": "2024-09-16", "reviewDays": 80 }, { "kNumber": "K242042", "deviceName": "TriALTIS™ Spine System", "productCode": "NKB", "decisionDate": "2024-09-09", "reviewDays": 59 }, { "kNumber": "K233684", "deviceName": "TriALTIS™ Spine System", "productCode": "NKB", "decisionDate": "2023-12-12", "reviewDays": 26 }, { "kNumber": "K233366", "deviceName": "SYMPHONY OCT System", "productCode": "NKG", "decisionDate": "2023-11-09", "reviewDays": 38 }, { "kNumber": "K232492", "deviceName": "2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor", "productCode": "MBI", "decisionDate": "2023-10-06", "reviewDays": 50 }, { "kNumber": "K231527", "deviceName": "TriALTIS Navigation Enabled Instruments", "productCode": "OLO", "decisionDate": "2023-09-29", "reviewDays": 126 } ], "nameVariants": { "total": "6", "shown": [ { "name": "MEDOS INTERNATIONAL SARL", "dataset": "device/registrationlisting", "method": "normalised" }, { "name": "Medos International SARL", "dataset": "device/510k", "method": "normalised" }, { "name": "Medos International Sarl", "dataset": "device/recall", "method": "normalised" }, { "name": "Medos International Sarl", "dataset": "device/enforcement", "method": "normalised" }, { "name": "Medos International Sàrl", "dataset": "device/510k", "method": "normalised" }, { "name": "Medos-International Sarl", "dataset": "device/510k", "method": "normalised" } ] }, "sources": { "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Medos%20International%20Sarl%22", "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Medos%20International%20Sarl%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": "2026-08-11T14:48:53.045Z" }