The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Polar Head.
| Device ID | K100761 |
| 510k Number | K100761 |
| Device Name: | BIOPRO POLAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| 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 | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-17 |
| Decision Date | 2010-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M209181520 | K100761 | 000 |
| M209181390 | K100761 | 000 |
| M209181380 | K100761 | 000 |
| M209181370 | K100761 | 000 |
| M209181360 | K100761 | 000 |
| M209181350 | K100761 | 000 |
| M209181340 | K100761 | 000 |
| M209181330 | K100761 | 000 |
| M209181320 | K100761 | 000 |
| M209181310 | K100761 | 000 |
| M209181400 | K100761 | 000 |
| M209181410 | K100761 | 000 |
| M209181420 | K100761 | 000 |
| M209181510 | K100761 | 000 |
| M209181500 | K100761 | 000 |
| M209181490 | K100761 | 000 |
| M209181480 | K100761 | 000 |
| M209181470 | K100761 | 000 |
| M209181460 | K100761 | 000 |
| M209181450 | K100761 | 000 |
| M209181440 | K100761 | 000 |
| M209181430 | K100761 | 000 |
| M209181300 | K100761 | 000 |