SHAPEMATCH CUTTING GUIDE


Device Classification Name

prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer

510(k) Number K122053
Device Name SHAPEMATCH CUTTING GUIDE
Applicant
STRYKER CORP.
1600 harbor bay drive
suite 200
alameda, 
CA 
94502

Applicant Contact tammy wharton
Correspondent
STRYKER CORP.
1600 harbor bay drive
suite 200
alameda, 
CA 
94502

Correspodent Contact tammy wharton
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OOG  
Date Received 07/13/2012
Decision Date 10/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls