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510(k) K213489

Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate by Wishbone Medical, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2022
Date Received
November 1, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
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)
  • K203467 — WishBone Medical Plate and Screw System (December 23, 2020)
  • 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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