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FDA 510(k)

WishBone Medical Plate and Screw System

K-Number: K203467 · 2020-12-23

ApplicantWishbone Medical, Inc.
Decision Date2020-12-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WishBone Medical Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K203467. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WishBone Medical Plate and Screw System?

WishBone Medical Plate and Screw System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K203467.

When did WishBone Medical Plate and Screw System receive FDA 510(k) clearance?

WishBone Medical Plate and Screw System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K203467.

Who is the listed applicant for WishBone Medical Plate and Screw System?

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

What is the FDA product code for WishBone Medical Plate and Screw System?

The FDA product code for WishBone Medical Plate and Screw System is HWC. This falls under the Cardiovascular category.

Other records listing Wishbone Medical, Inc. 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 PlateK193368Smart Correction SystemK182704WishBone Guided Growth System

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Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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