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FDA 510(k)

Tyber Medical Pin and Wire System (various)

K-Number: K231339 · 2023-07-06

ApplicantTyber Medical, LLC
Decision Date2023-07-06
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical Pin and Wire System (various) 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 2023-07-06 under 510(k) number K231339. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tyber Medical Pin and Wire System (various)?

Tyber Medical Pin and Wire System (various) is a medical device that received FDA 510(k) clearance on 2023-07-06. The listed applicant is Tyber Medical, LLC. The 510(k) number is K231339.

When did Tyber Medical Pin and Wire System (various) receive FDA 510(k) clearance?

Tyber Medical Pin and Wire System (various) received FDA 510(k) clearance on 2023-07-06, under 510(k) number K231339.

Who is the listed applicant for Tyber Medical Pin and Wire System (various)?

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 Pin and Wire System (various)?

The FDA product code for Tyber Medical Pin and Wire System (various) is HTY.

Other records listing Tyber Medical, LLC as applicant

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Related Devices (Code: HTY)

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.

K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical TechnologiesK241014Biomet Kirschner Wires (K-Wires)Biomet, 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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