CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM


Device Classification Name

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

510(k) Number K030151
Device Name CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
Original Applicant
HAYES MEDICAL, INC.
1115 windfield way, suite 100
el dorado hills, 
CA 
95762 -9623

Original Contact william j griffin
Regulation Number 888.3353
Classification Product Code
LZO  
Date Received 01/15/2003
Decision Date 04/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No