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FDA 510(k) Application Details - K230607
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K230607
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Southern Medical (Pty) Ltd
Building 10, Southern Implants Office Park
Irene 0062 ZA
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Contact
Nathan Wright
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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
03/03/2023
Decision Date
08/14/2023
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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