The following data is part of a premarket notification filed by Depuy Orthopaedics with the FDA for Depuy Gription Tf 5.5mm Sterile Locking Screws.
| Device ID | K123924 |
| 510k Number | K123924 |
| Device Name: | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DEPUY ORTHOPAEDICS 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Contact | Correne Ramy |
| Correspondent | Correne Ramy DEPUY ORTHOPAEDICS 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295381457 | K123924 | 000 |
| 10603295381310 | K123924 | 000 |
| 10603295381327 | K123924 | 000 |
| 10603295381334 | K123924 | 000 |
| 10603295381341 | K123924 | 000 |
| 10603295381358 | K123924 | 000 |
| 10603295381365 | K123924 | 000 |
| 10603295381372 | K123924 | 000 |
| 10603295381389 | K123924 | 000 |
| 10603295381396 | K123924 | 000 |
| 10603295381402 | K123924 | 000 |
| 10603295381419 | K123924 | 000 |
| 10603295381426 | K123924 | 000 |
| 10603295381433 | K123924 | 000 |
| 10603295381440 | K123924 | 000 |
| 10603295381303 | K123924 | 000 |