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FDA 510(k)

JONES-FX FRACTURE SYSTEM

K-Number: K131620 · 2013-07-25

ApplicantInstratek, Inc.
Decision Date2013-07-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JONES-FX FRACTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 2013-07-25 under 510(k) number K131620. 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 JONES-FX FRACTURE SYSTEM?

JONES-FX FRACTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-25. The listed applicant is Instratek, Inc.. The 510(k) number is K131620.

When did JONES-FX FRACTURE SYSTEM receive FDA 510(k) clearance?

JONES-FX FRACTURE SYSTEM received FDA 510(k) clearance on 2013-07-25, under 510(k) number K131620.

Who is the listed applicant for JONES-FX FRACTURE SYSTEM?

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

What is the FDA product code for JONES-FX FRACTURE SYSTEM?

The FDA product code for JONES-FX FRACTURE SYSTEM is HWC. This falls under the Cardiovascular category.

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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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