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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 a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2023-07-06 under approval 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. It is manufactured by Tyber Medical, LLC. The 510(k) number is K231339.

When was Tyber Medical Pin and Wire System (various) approved by the FDA?

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

What company makes Tyber Medical Pin and Wire System (various)?

Tyber Medical Pin and Wire System (various) is manufactured by Tyber Medical, LLC.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

Other Devices by Tyber Medical, LLC

K161597Tyber Medical BioTy® Nanotopography Trauma Screw K153575Tyber Medical Trauma Screw K172185Tyber Medical PT Interbody Spacer System K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw K171327Tyber Medical Wedge System K180590Tyber Medical PT Interbody Spacer System

View all 24 devices →

Related Devices (Code: HTY)

K161489Syntorr K-wire and Pin SystemSyntorr, Inc. K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC K160194StarFuse Interphalangeal PinPhalanx Innovations K152662S-WireSpinal Resources, Inc. K153204In2Bones Kirschner wireIn2bones Sas K152627IFS Fixation Scaffold SystemMetric Medical Devices, 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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