The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Modification To Reflection Cross-linked Uhmwpe Acetabular Components.
| Device ID | K013658 |
| 510k Number | K013658 |
| Device Name: | MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2001-12-05 |
| Summary: | summary |