METAFIX FEMORAL HIP STEM SIZE 1


Device Classification Name

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

510(k) Number K121439
Device Name METAFIX FEMORAL HIP STEM SIZE 1
Applicant
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa, 
FL 
33612

Applicant Contact lucinda gerber
Correspondent
CORIN U.S.A.
10500 university center dr.,
suite 190
tampa, 
FL 
33612

Correspodent Contact lucinda gerber
Regulation Number 888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY  
Date Received 05/15/2012
Decision Date 09/14/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized