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FDA 510(k)

Hercules Syndesmosis Implant System

K-Number: K220260 · 2022-03-31

ApplicantIn2bones USA, LLC
Decision Date2022-03-31
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hercules Syndesmosis Implant System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2022-03-31 under 510(k) number K220260. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hercules Syndesmosis Implant System?

Hercules Syndesmosis Implant System is a medical device that received FDA 510(k) clearance on 2022-03-31. The listed applicant is In2bones USA, LLC. The 510(k) number is K220260.

When did Hercules Syndesmosis Implant System receive FDA 510(k) clearance?

Hercules Syndesmosis Implant System received FDA 510(k) clearance on 2022-03-31, under 510(k) number K220260.

Who is the listed applicant for Hercules Syndesmosis Implant System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hercules Syndesmosis Implant System?

The FDA product code for Hercules Syndesmosis Implant System is HTN.

Other records listing In2bones USA, LLC as applicant

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, 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.

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