TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE


Device Classification Name

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

510(k) Number K072575
Device Name TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE
Applicant
STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact tiffani rogers
Correspondent
STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact tiffani rogers
Regulation Number 888.3565
Classification Product Code
MBH  
Date Received 09/13/2007
Decision Date 01/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No