The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599.
| Device ID | K061089 |
| 510k Number | K061089 |
| Device Name: | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 |
| 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 | 2006-04-18 |
| Decision Date | 2006-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209202840 | K061089 | 000 |
| M209173510 | K061089 | 000 |
| M209173740 | K061089 | 000 |
| M209173830 | K061089 | 000 |
| M209173870 | K061089 | 000 |
| M209188170 | K061089 | 000 |
| M209188810 | K061089 | 000 |
| M209189210 | K061089 | 000 |
| M209189290 | K061089 | 000 |
| M209191250 | K061089 | 000 |
| M209193990 | K061089 | 000 |
| M209195320 | K061089 | 000 |
| M209195330 | K061089 | 000 |
| M209195340 | K061089 | 000 |
| M209195350 | K061089 | 000 |
| M209197580 | K061089 | 000 |
| M209173400 | K061089 | 000 |
| M20922864 | K061089 | 000 |
| M209175960 | K061089 | 000 |
| M209175970 | K061089 | 000 |
| M209175980 | K061089 | 000 |
| M209175990 | K061089 | 000 |
| M209176000 | K061089 | 000 |
| M209176010 | K061089 | 000 |
| M209176030 | K061089 | 000 |
| M209202340 | K061089 | 000 |
| M209202350 | K061089 | 000 |
| M209202360 | K061089 | 000 |
| M209202370 | K061089 | 000 |
| M20922860 | K061089 | 000 |
| M20922861 | K061089 | 000 |
| M20922862 | K061089 | 000 |
| M20922863 | K061089 | 000 |
| M209197590 | K061089 | 000 |
| M209197600 | K061089 | 000 |
| M209172670 | K061089 | 000 |
| M209173450 | K061089 | 000 |
| M209173460 | K061089 | 000 |
| M209173470 | K061089 | 000 |
| M209173480 | K061089 | 000 |
| M209176130 | K061089 | 000 |
| M209176140 | K061089 | 000 |
| M209176150 | K061089 | 000 |
| M209176160 | K061089 | 000 |
| M209182760 | K061089 | 000 |
| M209182770 | K061089 | 000 |
| M209182780 | K061089 | 000 |
| M2091946110 | K061089 | 000 |
| M209194620 | K061089 | 000 |
| M209194630 | K061089 | 000 |
| M209172660 | K061089 | 000 |
| M209172650 | K061089 | 000 |
| M209197610 | K061089 | 000 |
| M209198020 | K061089 | 000 |
| M209198060 | K061089 | 000 |
| M209198070 | K061089 | 000 |
| M209198080 | K061089 | 000 |
| M209198090 | K061089 | 000 |
| M209198200 | K061089 | 000 |
| M209198320 | K061089 | 000 |
| M209200630 | K061089 | 000 |
| M209200660 | K061089 | 000 |
| M209172600 | K061089 | 000 |
| M209172610 | K061089 | 000 |
| M209172620 | K061089 | 000 |
| M209172630 | K061089 | 000 |
| M209172640 | K061089 | 000 |
| M209216910 | K061089 | 000 |