SYNTHES 6.5 MM CANNULATED SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K021932
Device Name SYNTHES 6.5 MM CANNULATED SCREW
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact bonnie j smith
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
OUR  
Date Received 06/12/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No