K071160 is an FDA 510(k) clearance for the REFLECTION, TANDEM UNIPOLAR. 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 October 5, 2007, 162 days after receiving the submission on April 26, 2007.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K071160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2007 |
| Decision Date | October 05, 2007 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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 |