CONSTRAINED LINER


Device Classification Name

prosthesis, hip, constrained, cemented or uncemented, metal/polymer

510(k) Number K023794
Device Name CONSTRAINED LINER
Original Applicant
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin, 
TX 
78758

Original Contact debbie de los santos
Regulation Number 888.3310
Classification Product Code
KWZ  
Date Received 11/13/2002
Decision Date 04/01/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No