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FDA 510(k) Application Details - K172594
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K172594
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Spine Wave, Inc.
3 Enterprise Drive
Suite 210
Shelton, CT 06484 US
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Contact
Amy Noccioli
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
08/29/2017
Decision Date
12/15/2017
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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