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FDA 510(k) Application Details - K223731
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K223731
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Nuvasive, Inc.
7475 Lusk Blvd.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Meet Vaghani
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
12/13/2022
Decision Date
01/12/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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