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510(k) K230527

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2023
Date Received
February 27, 2023
Clearance Type
Special
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)
  • 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)
  • K180736 — WishBone Medical Plate and Screw System (October 4, 2018)
  • K173013 — WishBone K-Wire System (December 14, 2017)

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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