The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Resufacing Patella Size 4.
Device ID | K113571 |
510k Number | K113571 |
Device Name: | GMK RESUFACING PATELLA SIZE 4 |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
Contact | Adam Gross |
Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-02 |
Decision Date | 2012-01-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07630030815775 | K113571 | 000 |