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FDA 510(k)

OrthoSolutions 'System26' Bone Screws

K-Number: K163489 · 2017-03-08

ApplicantOrtho Solutions UK Limited
Decision Date2017-03-08
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OrthoSolutions 'System26' Bone Screws is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions UK Limited. It received FDA 510(k) clearance on 2017-03-08 under 510(k) number K163489. 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 OrthoSolutions 'System26' Bone Screws?

OrthoSolutions 'System26' Bone Screws is a medical device that received FDA 510(k) clearance on 2017-03-08. The listed applicant is Ortho Solutions UK Limited. The 510(k) number is K163489.

When did OrthoSolutions 'System26' Bone Screws receive FDA 510(k) clearance?

OrthoSolutions 'System26' Bone Screws received FDA 510(k) clearance on 2017-03-08, under 510(k) number K163489.

Who is the listed applicant for OrthoSolutions 'System26' Bone Screws?

The FDA 510(k) record lists Ortho Solutions UK Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoSolutions 'System26' Bone Screws?

The FDA product code for OrthoSolutions 'System26' Bone Screws is HWC. This falls under the Cardiovascular category.

Other records listing Ortho Solutions UK Limited 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.

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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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