SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM


Device Classification Name

plate, bone

510(k) Number K030069
Device Name SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
Original Applicant
SYNTHES (USA)
1690 russell rd.
post office box 1766
paoli, 
PA 
19301

Original Contact bonnie j smith
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 01/08/2003
Decision Date 04/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No