MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K112158
Device Name MODULUS STEMS, MODULUS NECKS, 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 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY   KWZ  
Date Received 07/27/2011
Decision Date 05/10/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No