CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS


Device Classification Name

hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

510(k) Number K111481
Device Name CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS
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
OQI  
Subsequent Product Codes
LZO   MEH  
Date Received 05/27/2011
Decision Date 02/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No