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FDA 510(k) Application Details - K021324
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K021324
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.
3 HASADNOAT ST.
HERZLIA 46728 IL
Other 510(k) Applications for this Company
Contact
YAEL RUBIN
Other 510(k) Applications for this Contact
Regulation Number
888.3020
More FDA Info for this Regulation Number
Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2002
Decision Date
05/23/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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