FDA Inspection
Linvatec Corp. dba ConMed LinvatecLinvatec Corp. dba ConMed Linvatec – FDA Inspection, Mar 24, 2026
Record Details
This FDA Inspection record concerns Linvatec Corp. dba ConMed Linvatec, with an inspection on March 24, 2026, issued by the Florida District Office, covering medical devices & rad health.
- Inspection Date
- March 24, 2026
- Product Type
- Medical Devices & Rad Health
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ID · e53e8897-b487-4266-9c2a-4d00ec88ca0d
Inspection Facts
- Inspection number
- 1309064
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management
- ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Linvatec Corp. dba ConMed Linvatec
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2017 | Not classified | Florida District Office | |
| August 6, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 25, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Linvatec Corp. dba ConMed Linvatec
- FDA Inspection 1226977 - 2023-12-14
- FDA Inspection 1053500 - 2017-11-03
- FDA Inspection 843245 - 2013-08-06
- FDA Inspection 716814 - 2011-03-25
- FDA Inspection 677180 - 2010-08-26
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