The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro K-wire, Models 16863, 17231, 17232, 18577, 18682-18685.
| Device ID | K083490 |
| 510k Number | K083490 |
| Device Name: | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209192360 | K083490 | 000 |
| 00810012485227 | K083490 | 000 |
| 00810012485210 | K083490 | 000 |
| 00810012485203 | K083490 | 000 |
| 00810012485166 | K083490 | 000 |
| 00810012485159 | K083490 | 000 |
| 00810012485142 | K083490 | 000 |
| 00810012485135 | K083490 | 000 |
| 00810012485128 | K083490 | 000 |
| 00810012482424 | K083490 | 000 |
| 00810012481922 | K083490 | 000 |
| 00810012481915 | K083490 | 000 |
| 00810012481908 | K083490 | 000 |
| 00810012485777 | K083490 | 000 |
| 00810012485760 | K083490 | 000 |
| 00810012485753 | K083490 | 000 |
| 00810012485746 | K083490 | 000 |
| 00810012485234 | K083490 | 000 |
| 00810012485241 | K083490 | 000 |
| 00810012485258 | K083490 | 000 |
| M209192350 | K083490 | 000 |
| M209192340 | K083490 | 000 |
| 00810012485289 | K083490 | 000 |
| 00810012485265 | K083490 | 000 |
| 00810012482431 | K083490 | 000 |
| 00810012481892 | K083490 | 000 |
| 00810012481885 | K083490 | 000 |
| 00810012481878 | K083490 | 000 |
| 00810012481861 | K083490 | 000 |
| 00810012481854 | K083490 | 000 |
| 00810012485340 | K083490 | 000 |
| 00810012485326 | K083490 | 000 |
| 00810012485319 | K083490 | 000 |
| 00810012485302 | K083490 | 000 |
| 00810012485296 | K083490 | 000 |
| 00810012485272 | K083490 | 000 |
| 00810012481847 | K083490 | 000 |