K-FIX


Device Classification Name

pin, fixation, smooth

510(k) Number K022597
Device Name K-FIX
Original Applicant
NEWDEAL S.A.
9109 copenhaver dr.
potomac, 
MD 
20854

Original Contact norman f estrin
Regulation Number 888.3040
Classification Product Code
HTY  
Date Received 08/05/2002
Decision Date 11/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No