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

Screw, Fixation, Bone

ASCENSION ORTHOPEDICS

The following data is part of a premarket notification filed by Ascension Orthopedics with the FDA for Integra® Capture™ Screw System & Integra® Ti6® Internal Fixation System.

Pre-market Notification Details

• Device ID: K162153
• 510k Number: K162153
• Device Name: Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System
• Classification: Screw, Fixation, Bone
• Applicant: ASCENSION ORTHOPEDICS 8700 CAMERON ROAD, SUITE 100 Austin, TX 78754
• Contact: Gabriella Becker
• Correspondent: Blesson Abraham; ASCENSION ORTHOPEDICS 8700 CAMERON ROAD Austin, TX 78701
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-02
• Decision Date: 2017-07-14
• Summary: summary