The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection 3-hole Shell With Asymmetric Porous Coating.
| Device ID | K060630 |
| 510k Number | K060630 |
| Device Name: | REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-09 |
| Decision Date | 2006-06-14 |
| Summary: | summary |