NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K022323
Device Name NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
Original Applicant
OSTEOMEDICS, INC.
809 carter ln.
paramus, 
NJ 
07652

Original Contact albert enayati
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 07/17/2002
Decision Date 09/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No