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FDA 510(k) Application Details - K123810
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
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510(K) Number
K123810
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
CARBOFIX ORTHOPEDICS LTD.
11 HA'HOSHLIM STREET
HERZELIYA 46724 IL
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Contact
YAEL RUBIN
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
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More FDA Info for this Product Code
Date Received
12/11/2012
Decision Date
06/14/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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