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FDA 510(k)

FRAG-LOC SYSTEM

K-Number: K130986 · 2013-07-23

ApplicantAcumed, LLC
Decision Date2013-07-23
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRAG-LOC 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 2013-07-23 under 510(k) number K130986. 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 FRAG-LOC SYSTEM?

FRAG-LOC SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-23. The listed applicant is Acumed, LLC. The 510(k) number is K130986.

When did FRAG-LOC SYSTEM receive FDA 510(k) clearance?

FRAG-LOC SYSTEM received FDA 510(k) clearance on 2013-07-23, under 510(k) number K130986.

Who is the listed applicant for FRAG-LOC 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 FRAG-LOC SYSTEM?

The FDA product code for FRAG-LOC SYSTEM is HTN.

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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: 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.

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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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