The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Physica System.
| Device ID | K201084 |
| 510k Number | K201084 |
| Device Name: | Physica System |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | LimaCorporate S.p.A. Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Michela Zanotto |
| Correspondent | Stephen Peoples Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
| Product Code | MBH |
| Subsequent Product Code | HRY |
| Subsequent Product Code | JWH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-23 |
| Decision Date | 2020-12-14 |