CAPTURE™ High Torque Screw System CSS500000640WT

GUDID 10381780123040

The washer is used in conjunction with the Capture High Torque Screw System.

Ascension Orthopedics, Inc.

Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer

• Primary Device ID: 10381780123040
• NIH Device Record Key: aa594183-76a3-4b3e-82f8-96e85171e21e
• Commercial Distribution Discontinuation: 2026-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPTURE™ High Torque Screw System
• Version Model Number: CSS500000640WT
• Catalog Number: CSS500000640WT
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780123040 [Primary]
HIBCC	M268CSS500000640WT1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092440

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

[10381780123040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-09-18
• Device Publish Date: 2017-10-09

On-Brand Devices [CAPTURE™ High Torque Screw System]

• M268HITORQ7IMP1: The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws
• M268HITORQ45IMP1: The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws
• M268HITORQ23IMP1: The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws
• 10381780123064: The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123057: The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123040: The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123033: The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123026: The washer is used in conjunction with the Capture High Torque Screw System.