The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for 3-piece Proximal Humeral Replacement System.
| Device ID | K020045 |
| 510k Number | K020045 |
| Device Name: | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET ORTHOPEDICS, INC. 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 | 2002-01-07 |
| Decision Date | 2002-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304370500 | K020045 | 000 |
| 00880304215689 | K020045 | 000 |
| 00880304215696 | K020045 | 000 |
| 00880304215702 | K020045 | 000 |
| 00880304215719 | K020045 | 000 |
| 00880304215726 | K020045 | 000 |
| 00880304370463 | K020045 | 000 |
| 00880304370470 | K020045 | 000 |
| 00880304370487 | K020045 | 000 |
| 00880304370494 | K020045 | 000 |
| 00880304215672 | K020045 | 000 |