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FDA 510(k) Application Details - K230867
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K230867
Device Name
Screw, Fixation, Bone
Applicant
University of Utah, Department of Orthopaedics
590 Wakara Way
Salt Lake City, UT 84108 US
Other 510(k) Applications for this Company
Contact
Wade Fallin
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
03/29/2023
Decision Date
06/26/2023
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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