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FDA 510(k) Application Details - K200863
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K200863
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
CoreLink, LLC
2072 Fenton Logistics Blvd.
St. Louis, MO 63206 US
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Contact
Steve Mounts
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2020
Decision Date
04/28/2020
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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