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FDA 510(k) Application Details - K192526
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K192526
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Spine Wave, Inc.
3 Enterprise Drive, Suite 210
Shelton, CT 06484 US
Other 510(k) Applications for this Company
Contact
Amy Noccioli
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2019
Decision Date
10/10/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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