FDA 510(k)

Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System

K-Number: K162153 · 2017-07-14

Decision Date2017-07-14

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System is a medical device manufactured by Ascension Orthopedics. It received FDA 510(k) clearance on 2017-07-14 under approval number K162153. 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 Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System?

Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Ascension Orthopedics. The 510(k) number is K162153.

When was Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System approved by the FDA?

Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System received FDA 510(k) clearance on 2017-07-14, under approval number K162153.

What company makes Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System?

Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System is manufactured by Ascension Orthopedics.

What is the FDA product code for Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System?

The FDA product code for Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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Other Devices by Ascension Orthopedics

K160830Integra External Fixation System K182878Integra Salto Total Ankle System

Related Devices (Code: HWC)

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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.