ACETABULAR PLATES


Device Classification Name

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

510(k) Number K002941
Device Name ACETABULAR PLATES
Original Applicant
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin, 
TX 
78758

Original Contact j.d. webb
Regulation Number 888.3360
Classification Product Code
LWJ  
Date Received 09/21/2000
Decision Date 12/04/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No