The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Cocr Bi-angular Humeral Component.
| Device ID | K961571 |
| 510k Number | K961571 |
| Device Name: | COCR BI-ANGULAR HUMERAL COMPONENT |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | John Waggoner |
| Correspondent | John Waggoner BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-23 |
| Decision Date | 1996-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304215122 | K961571 | 000 |
| 00880304003927 | K961571 | 000 |
| 00880304003910 | K961571 | 000 |