SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP – MR SAFE


Device Classification Name

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

510(k) Number K030390
Device Name SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP – MR SAFE
Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Applicant Contact bonnie smith
Correspondent
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Correspodent Contact bonnie smith
Regulation Number 888.3030
Classification Product Code
LXT  
Date Received 02/05/2003
Decision Date 04/01/2003
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