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510(k) K203228

DART-FIRE EDGE Cannulated Screw System by Wright Medical — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2021
Date Received
November 2, 2020
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

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  • K901015 — WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC (November 5, 1990)
  • K892501 — WRIGHT MEDICAL FETASAFE (September 12, 1989)

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