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FDA 510(k) Application Details - K181440
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K181440
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
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Classification Product Code
NKG
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More FDA Info for this Product Code
Date Received
06/01/2018
Decision Date
07/30/2018
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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