CORIN OPTIMOM MODULAR HEAD


Device Classification Name

prosthesis, hip, hemi-, femoral, metal

510(k) Number K111911
Device Name CORIN OPTIMOM MODULAR HEAD
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 888.3360
Classification Product Code
KWL  
Date Received 07/05/2011
Decision Date 08/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No