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FDA 510(k)

Acumed Ankle Syndesmosis Repair System

K-Number: K212990 · 2022-01-07

ApplicantAcumed, LLC
Decision Date2022-01-07
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acumed Ankle Syndesmosis Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K212990. 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 Acumed Ankle Syndesmosis Repair System?

Acumed Ankle Syndesmosis Repair System is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Acumed, LLC. The 510(k) number is K212990.

When did Acumed Ankle Syndesmosis Repair System receive FDA 510(k) clearance?

Acumed Ankle Syndesmosis Repair System received FDA 510(k) clearance on 2022-01-07, under 510(k) number K212990.

Who is the listed applicant for Acumed Ankle Syndesmosis Repair System?

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

What is the FDA product code for Acumed Ankle Syndesmosis Repair System?

The FDA product code for Acumed Ankle Syndesmosis Repair System is HTN.

Other records listing Acumed, LLC 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.

K252356The Acumed Wrist Fixation System - 2.4mm ScrewsK251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsK251296The Acumed Wrist Fixation SystemK243624Acu-Sinch Knotless MiniK233311Acumed Wrist Plating SystemK230744Acumed Acutrak 3 Headless Compression Screw System

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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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