The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Kirschner Sholders With Titanium Plasma Spray.
| Device ID | K961260 |
| 510k Number | K961260 |
| Device Name: | KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 |
| Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-02 |
| Decision Date | 1997-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304387478 | K961260 | 000 |
| 00880304387461 | K961260 | 000 |
| 00880304387454 | K961260 | 000 |
| 00880304387447 | K961260 | 000 |
| 00880304387430 | K961260 | 000 |
| 00880304387423 | K961260 | 000 |
| 00880304377028 | K961260 | 000 |
| 00880304008755 | K961260 | 000 |