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FDA 510(k)

Akros Fibulink Syndesmosis Repair Kit

K-Number: K162805 · 2017-01-10

ApplicantAkros Medical
Decision Date2017-01-10
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Akros Fibulink Syndesmosis Repair Kit is the device name listed in this FDA 510(k) record. The listed applicant is Akros Medical. It received FDA 510(k) clearance on 2017-01-10 under 510(k) number K162805. 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 Akros Fibulink Syndesmosis Repair Kit?

Akros Fibulink Syndesmosis Repair Kit is a medical device that received FDA 510(k) clearance on 2017-01-10. The listed applicant is Akros Medical. The 510(k) number is K162805.

When did Akros Fibulink Syndesmosis Repair Kit receive FDA 510(k) clearance?

Akros Fibulink Syndesmosis Repair Kit received FDA 510(k) clearance on 2017-01-10, under 510(k) number K162805.

Who is the listed applicant for Akros Fibulink Syndesmosis Repair Kit?

The FDA 510(k) record lists Akros Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Akros Fibulink Syndesmosis Repair Kit?

The FDA product code for Akros Fibulink Syndesmosis Repair Kit is HTN.

Other records listing Akros Medical as applicant

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.

K200361Akros Scruture Anchor LisFranc Repair KitK173550Akros FibuLink™ Syndesmosis Repair Kit

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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