The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biomet Bi-polar Shoulder System.
| Device ID | K002998 |
| 510k Number | K002998 |
| Device Name: | BIOMET BI-POLAR SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bicke; |
| Correspondent | Tracy J Bicke; 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-26 |
| Decision Date | 2000-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304212466 | K002998 | 000 |
| 00880304212459 | K002998 | 000 |
| 00880304005242 | K002998 | 000 |
| 00880304003897 | K002998 | 000 |
| 00880304003446 | K002998 | 000 |
| 00880304002715 | K002998 | 000 |
| 00880304002371 | K002998 | 000 |