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FDA 510(k)

WishBone Guided Growth System

K-Number: K182704 · 2019-06-25

ApplicantWishbone Medical
Decision Date2019-06-25
Product CodeOBT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WishBone Guided Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K182704. 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 WishBone Guided Growth System?

WishBone Guided Growth System is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Wishbone Medical. The 510(k) number is K182704.

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

WishBone Guided Growth System received FDA 510(k) clearance on 2019-06-25, under 510(k) number K182704.

Who is the listed applicant for WishBone Guided Growth System?

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

What is the FDA product code for WishBone Guided Growth System?

The FDA product code for WishBone Guided Growth System is OBT.

Other records listing Wishbone Medical 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.

K231461Smart Correction System (HA Half Pins)K230527WishBone Medical Plate and Screw SystemK221366Smart Correction System Rings and Compatible HA-Coated Half PinsK213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateK203467WishBone Medical Plate and Screw SystemK193368Smart Correction System

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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.K180624Guided Growth Plate System PlusOrthofix SrlK172183Guided 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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