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FDA 510(k)

Guided Growth Plate System Plus

K-Number: K180624 · 2018-05-15

ApplicantOrthofix Srl
Decision Date2018-05-15
Product CodeOBT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Guided Growth Plate System Plus is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2018-05-15 under 510(k) number K180624. The device is classified under product code OBT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guided Growth Plate System Plus?

Guided Growth Plate System Plus is a medical device that received FDA 510(k) clearance on 2018-05-15. The listed applicant is Orthofix Srl. The 510(k) number is K180624.

When did Guided Growth Plate System Plus receive FDA 510(k) clearance?

Guided Growth Plate System Plus received FDA 510(k) clearance on 2018-05-15, under 510(k) number K180624.

Who is the listed applicant for Guided Growth Plate System Plus?

The FDA 510(k) record lists Orthofix Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Growth Plate System Plus?

The FDA product code for Guided Growth Plate System Plus is OBT.

Other records listing Orthofix Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAK250112FitboneTM TrochantericK242270OrthoNext Platform SystemK242861TrueLok ElevateK233867Fitbone Trochanteric

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Related Devices (Code: OBT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220190The GIRO Growth Modulation SystemPega Medical, Inc.K182704WishBone Guided Growth SystemWishbone MedicalK172183Guided Growth Plate System PlusOrthofix Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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