The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Corail Hip System, Revision Stem.
| Device ID | K093736 |
| 510k Number | K093736 |
| Device Name: | DEPUY CORAIL HIP SYSTEM, REVISION STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LZO |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-04 |
| Decision Date | 2011-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295262466 | K093736 | 000 |
| 10603295262305 | K093736 | 000 |
| 10603295262312 | K093736 | 000 |
| 10603295262329 | K093736 | 000 |
| 10603295262336 | K093736 | 000 |
| 10603295262343 | K093736 | 000 |
| 10603295262350 | K093736 | 000 |
| 10603295262367 | K093736 | 000 |
| 10603295262374 | K093736 | 000 |
| 10603295262381 | K093736 | 000 |
| 10603295262398 | K093736 | 000 |
| 10603295262404 | K093736 | 000 |
| 10603295262411 | K093736 | 000 |
| 10603295262428 | K093736 | 000 |
| 10603295262435 | K093736 | 000 |
| 10603295262442 | K093736 | 000 |
| 10603295262459 | K093736 | 000 |
| 10603295262299 | K093736 | 000 |