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FDA 510(k) Application Details - K230053
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K230053
Device Name
Screw, Fixation, Bone
Applicant
Stabiliz Orthopaedics Inc.
600 Eagleview Blvd
Unit 300
Exton, PA 19341 US
Other 510(k) Applications for this Company
Contact
Douglas Cerynik
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2023
Decision Date
04/19/2023
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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