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FDA 510(k) Application Details - K210182
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K210182
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
FloSpine
3651 FAU Blvd.., Suite 400
Boca Raton, FL 33431 US
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Contact
Peter Harris
Other 510(k) Applications for this Contact
Regulation Number
888.3060
More FDA Info for this Regulation Number
Classification Product Code
KWQ
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More FDA Info for this Product Code
Date Received
01/25/2021
Decision Date
04/07/2021
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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