SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS


Device Classification Name

screw, fixation, bone

510(k) Number K080943
Device Name SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact sheri l musgnung
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact sheri l musgnung
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 04/03/2008
Decision Date 04/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No