WishBone Guided Growth System— 510(k) K182704

Substantially Equivalent

Wishbone Medical

FDA 510(k) clearance K182704 for WishBone Guided Growth System, Substantially Equivalent on 2019-06-25. Applicant: Wishbone Medical. Device class: 2.

Clearance details

Applicant: Wishbone Medical
Product code: Code OBT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-09-27
Decision date: 2019-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBT

K220190 — The GIRO Growth Modulation System2022-10-24
K180624 — Guided Growth Plate System Plus2018-05-15
K172183 — Guided Growth Plate System Plus2018-01-09
K110805 — GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)2011-06-21
K093442 — GUIDED GROWTH SYSTEM2010-06-10

Recalls naming K182704

K-number listed on FDA's recall record

Z-1808-2024 — WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.Class II·Ongoing·Wishbone Medical, Inc.·20240405

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182704.

Data sourced from openFDA. This site is unofficial and independent of the FDA.