Panels › Physical Medicine › Product code NDA · Class 1
Helmet, Cranial, For Protective Use
Regulation 890.3025
0510(k)s in 12 months (0 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NDA
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet 3i, LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | Biomet 3i, LLC 3i Custom # 5753, OSCM2913, 2.9MMX 3.4MM X 13MM, OSSEOTITE CUSTOM, MICROMINI IMPLANT, LOT # 470258, Sterile. Implant Innovations, Inc. 4555 Riverside Drive, Palm Beach Gardens, FL 33410.
Custom tempo Terminated |
NDA | K072642 |
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