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FDA 510(k) Application Details - K192354
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K192354
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Innovasis, Inc.
614 East 3900 South
Salt Lake City, UT 84107 US
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Contact
Marshall McCarthy
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
08/29/2019
Decision Date
09/24/2019
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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