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 |