The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Interlok / Ha Copeland Resurfacing Heads.
| Device ID | K010635 |
| 510k Number | K010635 |
| Device Name: | INTERLOK / HA COPELAND RESURFACING HEADS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBF |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-02 |
| Decision Date | 2001-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304204829 | K010635 | 000 |
| 00880304204812 | K010635 | 000 |
| 00880304204805 | K010635 | 000 |
| 00880304204799 | K010635 | 000 |
| 00880304204782 | K010635 | 000 |
| 00880304204775 | K010635 | 000 |
| 00880304204768 | K010635 | 000 |
| 00880304204751 | K010635 | 000 |