The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Physica Cr Knee System.
Device ID | K151266 |
510k Number | K151266 |
Device Name: | Physica CR Knee System |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | Limacorporate S.P.A. Via Nazionale, 52 Villanova Di San Daniele, IT 33038 |
Contact | Emanuele Buttazzoni |
Correspondent | Stephen Peoples PEOPLE & ASSOCIATES CONSULTING LLC 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 | 2015-05-13 |
Decision Date | 2015-10-06 |
Summary: | summary |