The following data is part of a premarket notification filed by Depuy Orthopaedics with the FDA for Depuy M-spec 36mm Femoral Heads.
| Device ID | K120599 |
| 510k Number | K120599 |
| Device Name: | DEPUY M-SPEC 36MM FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DEPUY ORTHOPAEDICS 700 ORTHOPAEDIC DRIVE Correne Ramy, IN 46582 |
| Contact | Correne Ramy |
| Correspondent | Correne Ramy DEPUY ORTHOPAEDICS 700 ORTHOPAEDIC DRIVE Correne Ramy, IN 46582 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2013-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033998 | K120599 | 000 |
| 10603295001379 | K120599 | 000 |
| 10603295001386 | K120599 | 000 |
| 10603295001393 | K120599 | 000 |
| 10603295001409 | K120599 | 000 |
| 10603295033226 | K120599 | 000 |
| 10603295033363 | K120599 | 000 |
| 10603295033387 | K120599 | 000 |
| 10603295033509 | K120599 | 000 |
| 10603295033523 | K120599 | 000 |
| 10603295033547 | K120599 | 000 |
| 10603295001362 | K120599 | 000 |