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510(k) K221366

Smart Correction System Rings and Compatible HA-Coated Half Pins by Wishbone Medical, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2022
Date Received
May 12, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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)
  • 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)
  • K180736 — WishBone Medical Plate and Screw System (October 4, 2018)
  • K173013 — WishBone K-Wire System (December 14, 2017)

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