K231448 is an FDA 510(k) clearance for the TANDEM Hip System. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II - Special Controls, product code LZY).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 19, 2023, 62 days after receiving the submission on May 18, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K231448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2023 |
| Decision Date | July 19, 2023 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |