SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component, metal composite

510(k) Number K073135
Device Name SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
Applicant
SYNTHES (USA)
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact jill sherman
Correspondent
SYNTHES (USA)
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact jill sherman
Regulation Number 888.3030
Classification Product Code
LXT  
Date Received 11/07/2007
Decision Date 01/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No