SYNTHES (USA) MODULAR BLADE PLATE SYSTEM


Device Classification Name

appliance, fixation, nail/blade/plate combination, single component

510(k) Number K080109
Device Name SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
Applicant
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Applicant Contact jill r sherman
Correspondent
SYNTHES (USA)
1301 goshen pkwy
west chester, 
PA 
19380

Correspodent Contact jill r sherman
Regulation Number 888.3030
Classification Product Code
KTW  
Date Received 01/15/2008
Decision Date 03/20/2008
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