K201519 is an FDA 510(k) clearance for the PROFEMUR? GLADIATOR? Cemented Classic Stem. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on December 10, 2020, 185 days after receiving the submission on June 8, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K201519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2020 |
| Decision Date | December 10, 2020 |
| Days to Decision | 185 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 |