SMR SHOULDER SYSTEM- REVISION STEMS


Device Classification Name

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

510(k) Number K111212
Device Name SMR SHOULDER SYSTEM- REVISION STEMS
Applicant
LIMACORPORATE S.P.A.
p.o. box 696
winona lake, 
IN 
46590 -696

Applicant Contact cheryl hastings
Correspondent
LIMACORPORATE S.P.A.
p.o. box 696
winona lake, 
IN 
46590 -696

Correspodent Contact cheryl hastings
Regulation Number 888.3660
Classification Product Code
KWS  
Subsequent Product Code
HSD  
Date Received 04/29/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No