The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection Crosslinked Uhmwpe Acetabular Components.
| Device ID | K991026 |
| 510k Number | K991026 |
| Device Name: | REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Ehab M Esmail |
| Correspondent | Ehab M Esmail SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-29 |
| Decision Date | 1999-10-22 |
| Summary: | summary |