The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Medacta Bipolar Head.
| Device ID | K091967 |
| 510k Number | K091967 |
| Device Name: | MEDACTA BIPOLAR HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Contact | Natalie J Kennel |
| Correspondent | Natalie J Kennel MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030843914 | K091967 | 000 |
| 07630030843594 | K091967 | 000 |
| 07630030843532 | K091967 | 000 |
| 07630030843518 | K091967 | 000 |
| 07630030843495 | K091967 | 000 |
| 07630030843471 | K091967 | 000 |
| 07630030843457 | K091967 | 000 |
| 07630030843433 | K091967 | 000 |
| 07630030843419 | K091967 | 000 |
| 07630030843396 | K091967 | 000 |
| 07630030843372 | K091967 | 000 |
| 07630030843358 | K091967 | 000 |
| 07630030843334 | K091967 | 000 |
| 07630030843310 | K091967 | 000 |
| 07630030843617 | K091967 | 000 |
| 07630030843631 | K091967 | 000 |
| 07630030843891 | K091967 | 000 |
| 07630030843877 | K091967 | 000 |
| 07630030843853 | K091967 | 000 |
| 07630030843839 | K091967 | 000 |
| 07630030843815 | K091967 | 000 |
| 07630030843792 | K091967 | 000 |
| 07630030843778 | K091967 | 000 |
| 07630030843754 | K091967 | 000 |
| 07630030843730 | K091967 | 000 |
| 07630030843716 | K091967 | 000 |
| 07630030843693 | K091967 | 000 |
| 07630030843679 | K091967 | 000 |
| 07630030843655 | K091967 | 000 |
| 07630030843297 | K091967 | 000 |