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510(k) K180736

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2018
Date Received
March 22, 2018
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)
  • K213489 — Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula (January 27, 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)
  • K173013 — WishBone K-Wire System (December 14, 2017)

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