STRYKER PATIENT SPECIFIC CUTTING GUIDE


Device Classification Name

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

510(k) Number K110533
Device Name STRYKER PATIENT SPECIFIC CUTTING GUIDE
Applicant
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact karen ariemma
Correspondent
STRYKER CORP.
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact karen ariemma
Regulation Number 888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   OOG  
Date Received 02/24/2011
Decision Date 05/19/2011
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