CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE


Device Classification Name

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

510(k) Number K021466
Device Name CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
Original Applicant
HAYES MEDICAL, INC.
1115 windfield way, suite 100
el dorado hills, 
CA 
95762 -9623

Original Contact william j griffin
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 05/07/2002
Decision Date 07/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No