The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Subtalar Implant.
| Device ID | K041936 |
| 510k Number | K041936 |
| Device Name: | BIOPRO SUBTALAR IMPLANT |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-19 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209230420 | K041936 | 000 |
| 00810012480321 | K041936 | 000 |
| 00810012480338 | K041936 | 000 |
| 00810012480345 | K041936 | 000 |
| M20922567 | K041936 | 000 |
| M20922642 | K041936 | 000 |
| M20922643 | K041936 | 000 |
| M20922644 | K041936 | 000 |
| M20922645 | K041936 | 000 |
| M20922646 | K041936 | 000 |
| M20922647 | K041936 | 000 |
| M20922648 | K041936 | 000 |
| M20922650 | K041936 | 000 |
| M20922652 | K041936 | 000 |
| 00810012480314 | K041936 | 000 |
| 00810012480307 | K041936 | 000 |
| 00810012480291 | K041936 | 000 |
| M20923014 | K041936 | 000 |
| M209170850 | K041936 | 000 |
| M209170860 | K041936 | 000 |
| M209170870 | K041936 | 000 |
| M209170880 | K041936 | 000 |
| M209170890 | K041936 | 000 |
| M209172210 | K041936 | 000 |
| M209172220 | K041936 | 000 |
| M209172230 | K041936 | 000 |
| M209172240 | K041936 | 000 |
| M209172250 | K041936 | 000 |
| M209174780 | K041936 | 000 |
| M209178030 | K041936 | 000 |
| M20922653 | K041936 | 000 |
| M20922654 | K041936 | 000 |
| M209172280 | K041936 | 000 |
| M209172800 | K041936 | 000 |
| M209173070 | K041936 | 000 |
| M209174550 | K041936 | 000 |
| M209174790 | K041936 | 000 |
| M209174810 | K041936 | 000 |
| M209175230 | K041936 | 000 |
| M209171940 | K041936 | 000 |
| 00841742100104 | K041936 | 000 |
| 00841742100111 | K041936 | 000 |
| 00841742100128 | K041936 | 000 |
| 00841742100135 | K041936 | 000 |
| 00841742100142 | K041936 | 000 |
| M209171930 | K041936 | 000 |
| M209171920 | K041936 | 000 |
| M209171910 | K041936 | 000 |
| M20922655 | K041936 | 000 |
| M20922656 | K041936 | 000 |
| M20922658 | K041936 | 000 |
| M20922659 | K041936 | 000 |
| M20922660 | K041936 | 000 |
| M20922661 | K041936 | 000 |
| M20922797 | K041936 | 000 |
| M209171850 | K041936 | 000 |
| M209171860 | K041936 | 000 |
| M209171870 | K041936 | 000 |
| M209171880 | K041936 | 000 |
| M209171890 | K041936 | 000 |
| M209171900 | K041936 | 000 |
| 00841742100159 | K041936 | 000 |