H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K112091
Device Name H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
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 888.3353
Classification Product Code
MEH  
Subsequent Product Code
JDI  
Date Received 07/21/2011
Decision Date 11/09/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No