FDA Inspection
Linvatec Corp. dba ConMed LinvatecLinvatec Corp. dba ConMed Linvatec – FDA Inspection, Mar 25, 2011
Record Details
This FDA Inspection record concerns Linvatec Corp. dba ConMed Linvatec, with an inspection on March 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 25, 2011
- Product Type
- Devices
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ID · 9db05f19-0cc2-4eaf-b78f-7241e29f5895
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716814
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Linvatec Corp. dba ConMed Linvatec
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2026 | Not classified | Florida District Office | Compliance: Medical Devices |
| 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 |
| August 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Linvatec Corp. dba ConMed Linvatec
- FDA Inspection 1309064 - 2026-03-24
- FDA Inspection 1226977 - 2023-12-14
- FDA Inspection 1053500 - 2017-11-03
- FDA Inspection 843245 - 2013-08-06
- FDA Inspection 677180 - 2010-08-26
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