K193398 is an FDA 510(k) clearance for the Summit DuoFix HA Coating. This device is classified as a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II - Special Controls, product code MEH).
Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 4, 2020, 60 days after receiving the submission on December 6, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K193398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2019 |
| Decision Date | February 04, 2020 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MEH — Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |