The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection 3 Acetabular System.
| Device ID | K061253 |
| 510k Number | K061253 |
| Device Name: | REFLECTION 3 ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Katie Logerot |
| Correspondent | Katie Logerot SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-04 |
| Decision Date | 2006-05-31 |
| Summary: | summary |