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FDA 510(k)

Acumed Acutrak 3 Headless Compression Screw System

K-Number: K230744 · 2023-06-09

ApplicantAcumed, LLC
Decision Date2023-06-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acumed Acutrak 3 Headless Compression Screw 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 2023-06-09 under 510(k) number K230744. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumed Acutrak 3 Headless Compression Screw System?

Acumed Acutrak 3 Headless Compression Screw System is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Acumed, LLC. The 510(k) number is K230744.

When did Acumed Acutrak 3 Headless Compression Screw System receive FDA 510(k) clearance?

Acumed Acutrak 3 Headless Compression Screw System received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230744.

Who is the listed applicant for Acumed Acutrak 3 Headless Compression Screw 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 Acutrak 3 Headless Compression Screw System?

The FDA product code for Acumed Acutrak 3 Headless Compression Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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.

NCT07473947Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent PatientsRECRUITING

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 SystemK221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

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Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, 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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