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FDA 510(k)

Tyber Medical Staple Fixation System (various)

K-Number: K221947 · 2022-10-20

ApplicantTyber Medical, LLC
Decision Date2022-10-20
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tyber Medical Staple Fixation System (various) is a medical device manufactured by Tyber Medical, LLC. It received FDA 510(k) clearance on 2022-10-20 under approval number K221947. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tyber Medical Staple Fixation System (various)?

Tyber Medical Staple Fixation System (various) is a medical device that received FDA 510(k) clearance on 2022-10-20. It is manufactured by Tyber Medical, LLC. The 510(k) number is K221947.

When was Tyber Medical Staple Fixation System (various) approved by the FDA?

Tyber Medical Staple Fixation System (various) received FDA 510(k) clearance on 2022-10-20, under approval number K221947.

What company makes Tyber Medical Staple Fixation System (various)?

Tyber Medical Staple Fixation System (various) is manufactured by Tyber Medical, LLC.

What is the FDA product code for Tyber Medical Staple Fixation System (various)?

The FDA product code for Tyber Medical Staple Fixation System (various) is JDR.

Related Clinical Trials

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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 41694722 Lessons from global materiovigilance systems: What India can learn? Perspectives in clinical research (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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: JDR)

K161426NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC K160813EasyStepStryker GmbH K153622First Ray Internal Bone Staple SystemFirst Ray, LLC K153770OS2(R)-VP Varisation StapleIn2bones Sas K153395OS2-C Compression StapleIn2bones Sas K153129dynaMX Tabbed StapleMx Orthopedics, Corp.

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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