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510(k) K231819

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw by Innovate Orthopaedics Limited — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2023
Date Received
June 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Innovate Orthopaedics Limited

  • K212547 — Quick-Start Screws (December 30, 2021)

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