K190911 is an FDA 510(k) clearance for the Physica KR Liner and SMR Reverse Humeral Liner. This device is classified as a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II - Special Controls, product code JWH).
Submitted by Limacorporate (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on November 26, 2019, 232 days after receiving the submission on April 8, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3560.
| 510(k) Number | K190911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2019 |
| Decision Date | November 26, 2019 |
| Days to Decision | 232 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JWH - Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3560 |