OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB


Device Classification Name

plate, bone

510(k) Number K022035
Device Name OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
Original Applicant
OSTEOMEDICS, INC.
809 carter ln.
paramus, 
NJ 
07652

Original Contact albert enyati
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 06/21/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No