The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507.
| Device ID | K052596 |
| 510k Number | K052596 |
| Device Name: | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Contact | David Mrak |
| Correspondent | David Mrak BIOPRO, INC. 17 SEVENTEENTH ST. Port Huron, MI 48060 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-21 |
| Decision Date | 2005-11-15 |
| Summary: | summary |