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FDA 510(k) Application Details - K190526
Device Classification Name
More FDA Info for this Device
510(K) Number
K190526
Device Name
High V+ Bone Cement, CarboClear« Fenestrated Pedicle Screws
Applicant
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St.
Herzeliya 4672411 IL
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Contact
Hila Wachsler-Avrahami
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Regulation Number
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Classification Product Code
PML
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Date Received
03/04/2019
Decision Date
09/19/2019
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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