FDA 510(k)

Tyber Medical Trauma Screw

K-Number: K192974 · 2020-01-08

Decision Date2020-01-08

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tyber Medical 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 2020-01-08 under 510(k) number K192974. 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 Trauma Screw?

Tyber Medical Trauma Screw is a medical device that received FDA 510(k) clearance on 2020-01-08. The listed applicant is Tyber Medical, LLC. The 510(k) number is K192974.

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

Tyber Medical Trauma Screw received FDA 510(k) clearance on 2020-01-08, under 510(k) number K192974.

Who is the listed applicant for Tyber Medical 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 Trauma Screw?

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

Other records listing Tyber Medical, LLC 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.

K261207Exalta Proximal Tibia Plating System K260810Anteralign LS coverplate K261060Navigated LLIF Impactable Tracker K253042Tyber Medical Trauma Screw K252901Tyber Medical Trauma Screw K252742Navigated Instruments

View all 27 devices →

Related Devices (Code: HWC)

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLC K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps Ortho K261154CoLink® & 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.