The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Asphere M-spec Head.
| Device ID | K082585 |
| 510k Number | K082585 |
| Device Name: | DEPUY ASPHERE M-SPEC HEAD |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| 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 | KWA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295034247 | K082585 | 000 |
| 10603295033530 | K082585 | 000 |
| 10603295033516 | K082585 | 000 |
| 10603295033394 | K082585 | 000 |
| 10603295033370 | K082585 | 000 |
| 10603295033233 | K082585 | 000 |
| 10603295033011 | K082585 | 000 |
| 10603295032991 | K082585 | 000 |
| 10603295032977 | K082585 | 000 |
| 10603295033554 | K082585 | 000 |
| 10603295033769 | K082585 | 000 |
| 10603295034001 | K082585 | 000 |
| 10603295033981 | K082585 | 000 |
| 10603295033967 | K082585 | 000 |
| 10603295033943 | K082585 | 000 |
| 10603295033929 | K082585 | 000 |
| 10603295033905 | K082585 | 000 |
| 10603295033806 | K082585 | 000 |
| 10603295033783 | K082585 | 000 |
| 10603295032953 | K082585 | 000 |