The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Patient Specific Acetabular Reconstruction Prosthesis.
| Device ID | K092098 |
| 510k Number | K092098 |
| Device Name: | PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Contact | Megan Bevill |
| Correspondent | Megan Bevill SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2010-01-22 |
| Summary: | summary |