The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Physica Kr Knee System.
Device ID | K141934 |
510k Number | K141934 |
Device Name: | PHYSICA KR KNEE SYSTEM |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | LIMACORPORATE S.P.A. VIA NAZIONALE 52 Villanova Di San Daniele, Udine, IT 33038 |
Contact | Emanuele Buttazzoni |
Correspondent | Stephen Peoples LIMACORPORATE S.P.A. 5010 Lodge Pole Lane Fort Wayne, IN 46814 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-17 |
Decision Date | 2015-04-02 |
Summary: | summary |