Guided Growth Plate System Plus— 510(k) K180624

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K180624 for Guided Growth Plate System Plus, Substantially Equivalent on 2018-05-15. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant: Orthofix Srl
Product code: Code OBT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-03-09
Decision date: 2018-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Bussolengo, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBT

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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

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