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510(k) K203467

WishBone Medical Plate and Screw System by Wishbone Medical, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2020
Date Received
November 25, 2020
Clearance Type
Special
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 Wishbone Medical, Inc.

  • K231461 — Smart Correction System (HA Half Pins) (June 16, 2023)
  • K230527 — WishBone Medical Plate and Screw System (March 29, 2023)
  • K221366 — Smart Correction System Rings and Compatible HA-Coated Half Pins (June 6, 2022)
  • K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula (January 27, 2022)
  • K193368 — Smart Correction System (September 18, 2020)
  • K182704 — WishBone Guided Growth System (June 25, 2019)
  • K180736 — WishBone Medical Plate and Screw System (October 4, 2018)
  • K173013 — WishBone K-Wire System (December 14, 2017)

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