CONSTRUX EXTERNAL FIXATION DEVICE


Device Classification Name

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

510(k) Number K111376
Device Name CONSTRUX EXTERNAL FIXATION DEVICE
Applicant
EBI, LLC
399 jefferson rd
parsippany, 
NJ 
07054

Applicant Contact margaret f crowe
Correspondent
EBI, LLC
399 jefferson rd
parsippany, 
NJ 
07054

Correspodent Contact margaret f crowe
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 05/16/2011
Decision Date 08/03/2011
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