K013658 is an FDA 510(k) clearance for the MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 5, 2001, 29 days after receiving the submission on November 6, 2001.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K013658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2001 |
| Decision Date | December 05, 2001 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |