The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Spa Porous Coated Proximal Sleeve.
| Device ID | K071059 |
| 510k Number | K071059 |
| Device Name: | DEPUY SPA POROUS COATED PROXIMAL SLEEVE |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Kathy Harris |
| Correspondent | Kathy Harris DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-11-09 |
| Summary: | summary |