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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 the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2022-10-20 under 510(k) 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. The listed applicant is Tyber Medical, LLC. The 510(k) number is K221947.

When did Tyber Medical Staple Fixation System (various) receive FDA 510(k) clearance?

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

Who is the listed applicant for Tyber Medical Staple Fixation 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 Staple Fixation System (various)?

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

Other records listing Tyber Medical, LLC as applicant

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Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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