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FDA 510(k) Application Details - K180754
Device Classification Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
More FDA Info for this Device
510(K) Number
K180754
Device Name
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant
Signature Orthopaedics Pty Ltd.
7 Sirius Road
Lane Cove 2066 AU
Other 510(k) Applications for this Company
Contact
Declan Brazil
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
NKB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/22/2018
Decision Date
12/07/2018
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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