FIXION INTERLOCKING NAIL (FIXION IL NAIL)


the company

Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K002783
Device Name FIXION INTERLOCKING NAIL (FIXION IL NAIL)
Original Applicant
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
columbia square
555 thirteenth street, nw
washington, 
DC 
20004 -1109

Original Contact jonathan s kahan
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 09/06/2000
Decision Date 12/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No