The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Bipolar Shoulder Prosthesis-shell(rd-113130/33, Biangular Modular Head(rd-113101/41/42,biomodular Modular Head(rd-113143.
| Device ID | K960363 |
| 510k Number | K960363 |
| Device Name: | BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 |
| Classification | Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or 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 | MJT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1997-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304003477 | K960363 | 000 |
| 00880304002722 | K960363 | 000 |
| 00880304001619 | K960363 | 000 |