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FDA 510(k) Application Details - K223231
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K223231
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
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
888.3080
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Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
10/18/2022
Decision Date
02/24/2023
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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