The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Tara Femoral Resurfacing Component.
| Device ID | K043542 |
| 510k Number | K043542 |
| Device Name: | BIOPRO TARA FEMORAL RESURFACING COMPONENT |
| Classification | Prosthesis, Hip, Femoral, Resurfacing |
| 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 | KXA |
| CFR Regulation Number | 888.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-23 |
| Decision Date | 2005-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209100930 | K043542 | 000 |
| M209100920 | K043542 | 000 |
| M209100910 | K043542 | 000 |
| M209100900 | K043542 | 000 |
| M209100890 | K043542 | 000 |
| M209100880 | K043542 | 000 |
| M209100870 | K043542 | 000 |
| M209100860 | K043542 | 000 |
| M209100850 | K043542 | 000 |