NORMED TITANIUM OSTEOTOMY PLATING SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K022325
Device Name NORMED TITANIUM OSTEOTOMY PLATING 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

Recalls CDRH Recalls