The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Copeland Mb Resurfacing Humeral Heads.
| Device ID | K010657 |
| 510k Number | K010657 |
| Device Name: | COPELAND MB RESURFACING HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara A Bailey |
| Correspondent | Sara A Bailey BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304204669 | K010657 | 000 |
| 00880304204652 | K010657 | 000 |
| 00880304204645 | K010657 | 000 |
| 00880304204638 | K010657 | 000 |
| 00880304204621 | K010657 | 000 |
| 00880304204614 | K010657 | 000 |
| 00880304204607 | K010657 | 000 |
| 00880304204591 | K010657 | 000 |