K162125 is an FDA 510(k) clearance for the MALUC™ Total Hip Arthroplasty System. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Surgtech, Inc. (Westlake, US). The FDA issued a Cleared decision on May 10, 2017, 282 days after receiving the submission on August 1, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K162125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2016 |
| Decision Date | May 10, 2017 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDI - Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |