The following data is part of a premarket notification filed by Limacorporate S.p.a with the FDA for Physica System.
| Device ID | K213381 |
| 510k Number | K213381 |
| Device Name: | Physica System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | LimaCorporate S.p.A Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
| Contact | Ilaria Giannuzzi |
| Correspondent | Lacey Harbour Lima USA Inc. 2001 NE Green Oaks Blvd. Ste. 100 Arlington, TX 76006 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-13 |
| Decision Date | 2021-12-17 |