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 |