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FDA 510(k)

ACUMED CLAVICLE SCREW SYSTEM

K-Number: K083144 · 2009-06-16

ApplicantAcumed, LLC
Decision Date2009-06-16
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED CLAVICLE 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 2009-06-16 under 510(k) number K083144. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED CLAVICLE SCREW SYSTEM?

ACUMED CLAVICLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-16. The listed applicant is Acumed, LLC. The 510(k) number is K083144.

When did ACUMED CLAVICLE SCREW SYSTEM receive FDA 510(k) clearance?

ACUMED CLAVICLE SCREW SYSTEM received FDA 510(k) clearance on 2009-06-16, under 510(k) number K083144.

Who is the listed applicant for ACUMED CLAVICLE 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 CLAVICLE SCREW SYSTEM?

The FDA product code for ACUMED CLAVICLE SCREW SYSTEM is JDW.

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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: JDW)

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.

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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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