The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Mectacer Biolox Forte-femoral Heads.
| Device ID | K073337 |
| 510k Number | K073337 |
| Device Name: | MECTACER BIOLOX FORTE-FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-28 |
| Decision Date | 2008-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030846779 | K073337 | 000 |
| 07630030846762 | K073337 | 000 |
| 07630030846755 | K073337 | 000 |
| 07630030846748 | K073337 | 000 |
| 07630030846731 | K073337 | 000 |
| 07630030846724 | K073337 | 000 |
| 07630030846717 | K073337 | 000 |
| 07630030846700 | K073337 | 000 |
| 07630030846694 | K073337 | 000 |