SYNTHES 6.5MM MIDFOOT FUSION BOLT


Device Classification Name

screw, fixation, bone

510(k) Number K081071
Device Name SYNTHES 6.5MM MIDFOOT FUSION BOLT
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact karl j nittinger
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact karl j nittinger
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 04/15/2008
Decision Date 05/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls