SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS


Device Classification Name

screw, fixation, intraosseous

510(k) Number K021850
Device Name SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact matthew m hull
Regulation Number 872.4880
Classification Product Code
DZL  
Date Received 06/05/2002
Decision Date 06/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No