The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Glenoid Component W/ Keel & W/ Posts.
| Device ID | K001046 |
| 510k Number | K001046 |
| Device Name: | BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | Cheryl Warsinske |
| Correspondent | Cheryl Warsinske BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-31 |
| Decision Date | 2000-06-08 |