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FDA 510(k)

Acu-Sinch Knotless Mini

K-Number: K243624 · 2025-01-23

ApplicantAcumed, LLC
Decision Date2025-01-23
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acu-Sinch Knotless Mini is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2025-01-23 under 510(k) number K243624. 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 Acu-Sinch Knotless Mini?

Acu-Sinch Knotless Mini is a medical device that received FDA 510(k) clearance on 2025-01-23. The listed applicant is Acumed, LLC. The 510(k) number is K243624.

When did Acu-Sinch Knotless Mini receive FDA 510(k) clearance?

Acu-Sinch Knotless Mini received FDA 510(k) clearance on 2025-01-23, under 510(k) number K243624.

Who is the listed applicant for Acu-Sinch Knotless Mini?

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 Acu-Sinch Knotless Mini?

The FDA product code for Acu-Sinch Knotless Mini 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 SystemK233311Acumed Wrist Plating SystemK230744Acumed Acutrak 3 Headless Compression Screw SystemK221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

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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.K242091Bolo Button SystemFusion Orthopedics

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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