REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N


Device Classification Name

prosthesis, shoulder, semi-constrained, metal/polymer cemented

510(k) Number K103835
Device Name REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
Applicant
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Applicant Contact avital merl-margulies
Correspondent
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Correspodent Contact avital merl-margulies
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received 12/30/2010
Decision Date 05/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No