The following data is part of a premarket notification filed by Limacorporate with the FDA for Physica Kr Liner And Smr Reverse Humeral Liner.
| Device ID | K190911 |
| 510k Number | K190911 |
| Device Name: | Physica KR Liner And SMR Reverse Humeral Liner |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | LimaCorporate Via Nazionale, 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Roberto Gabetta |
| Correspondent | David Mcgurl Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | JWH |
| Subsequent Product Code | HRY |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2019-11-26 |
| Summary: | summary |