FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K021324
Device Name FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
Original Applicant
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
3 hasadnoat st.
herzlia, 

IL

46728

Original Contact yael rubin
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 04/26/2002
Decision Date 05/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls