PROXILOCK HIP PROSTHESIS; SIZE 12/36


Device Classification Name

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

510(k) Number K022966
Device Name PROXILOCK HIP PROSTHESIS; SIZE 12/36
Original Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Original Contact marci halevi
Regulation Number 888.3360
Classification Product Code
LWJ  
Date Received 09/06/2002
Decision Date 10/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No