CAPTURE™ High Torque Screw System CSS500000630WT

GUDID 10381780123033

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

Ascension Orthopedics, Inc.

Implantable bone washer

• Primary Device ID: 10381780123033
• NIH Device Record Key: 19ac74d2-5a8b-4f41-8c3f-d0cf3e54e8cd
• Commercial Distribution Discontinuation: 2026-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPTURE™ High Torque Screw System
• Version Model Number: CSS500000630WT
• Catalog Number: CSS500000630WT
• 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	10381780123033 [Primary]
HIBCC	M268CSS500000630WT1 [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

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

Moist Heat or Steam Sterilization

[10381780123033]

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.