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FDA 510(k) Application Details - K223852
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
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510(K) Number
K223852
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Vy Spine, LLC
2236 Capital Circle NE, Suite 103-1
Tallahassee, FL 32308 US
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Contact
Jordan Hendrickson
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
12/22/2022
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
Special
Reviewed By Third Party
N
Expedited Review
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