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FDA 510(k) Application Details - K173047
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K173047
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142 US
Other 510(k) Applications for this Company
Contact
Randy Lewis
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2017
Decision Date
02/01/2018
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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