COREN TOTAL HIP SYSTEM


Device Classification Name

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

510(k) Number K103431
Device Name COREN TOTAL HIP SYSTEM
Applicant
CORENTEC CO., LTD
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact kevin a thomas
Correspondent
CORENTEC CO., LTD
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact kevin a thomas
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 11/23/2010
Decision Date 07/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No