RT-PLUS PE INSERT CLAMP


Device Classification Name

prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

510(k) Number K021714
Device Name RT-PLUS PE INSERT CLAMP
Original Applicant
PLUS ORTHOPEDICS
6055 lusk blvd.
san diego, 
CA 
92121 -2700

Original Contact hartmut loch
Regulation Number 888.3510
Classification Product Code
KRO  
Date Received 05/24/2002
Decision Date 06/21/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No