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FDA 510(k)

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

K-Number: K162153 · 2017-07-14

ApplicantAscension Orthopedics
Decision Date2017-07-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics. It received FDA 510(k) clearance on 2017-07-14 under 510(k) 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. The listed applicant is Ascension Orthopedics. The 510(k) number is K162153.

When did Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System?

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

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

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.

NCT07511478Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle FracturesCOMPLETED

Other records listing Ascension Orthopedics 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.

K233674Freedom Wrist Arthroplasty SystemK233670Ascension Silicone MCP; Ascension Silicone PIPK182878Integra Salto Total Ankle SystemK160830Integra External Fixation System

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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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