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FDA 510(k)

Flex-Thread Clavicle Pin System

K-Number: K163488 · 2017-03-20

ApplicantIntrafuse, LLC
Decision Date2017-03-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flex-Thread Clavicle Pin System is the device name listed in this FDA 510(k) record. The listed applicant is Intrafuse, LLC. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163488. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex-Thread Clavicle Pin System?

Flex-Thread Clavicle Pin System is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Intrafuse, LLC. The 510(k) number is K163488.

When did Flex-Thread Clavicle Pin System receive FDA 510(k) clearance?

Flex-Thread Clavicle Pin System received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163488.

Who is the listed applicant for Flex-Thread Clavicle Pin System?

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

What is the FDA product code for Flex-Thread Clavicle Pin System?

The FDA product code for Flex-Thread Clavicle Pin System is HSB.

Other records listing Intrafuse, 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.

K172943Flex-Thread Fibula Pin System

Related Devices (Code: HSB)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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