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FDA 510(k)

Tyber Medical BioTy® Nanotopography Trauma Screw

K-Number: K161597 · 2016-11-16

ApplicantTyber Medical, LLC
Decision Date2016-11-16
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical BioTy® Nanotopography Trauma Screw is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K161597. 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 Tyber Medical BioTy® Nanotopography Trauma Screw?

Tyber Medical BioTy® Nanotopography Trauma Screw is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Tyber Medical, LLC. The 510(k) number is K161597.

When did Tyber Medical BioTy® Nanotopography Trauma Screw receive FDA 510(k) clearance?

Tyber Medical BioTy® Nanotopography Trauma Screw received FDA 510(k) clearance on 2016-11-16, under 510(k) number K161597.

Who is the listed applicant for Tyber Medical BioTy® Nanotopography Trauma Screw?

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

What is the FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw?

The FDA product code for Tyber Medical BioTy® Nanotopography Trauma Screw is HWC. This falls under the Cardiovascular category.

Other records listing Tyber Medical, LLC as applicant

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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.

K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLCK261241TriMed Compression ScrewsTriMed, Inc.K254215Arthrex Beaming SystemArthrex, Inc.

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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