CAPTURE™ Screw System CAPDIGITIMP

GUDID M268CAPDIGITIMP1

The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The Digital Screw is a cannulated, threaded bone screw which is offered in a 2.0mm diameter with lengths of 24 – 50mm. The system includes instruments to facilitate the placement of the screws.

Ascension Orthopedics, Inc.

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• Primary Device ID: M268CAPDIGITIMP1
• NIH Device Record Key: bb449bda-3db8-4748-8db9-8b997f2efc7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAPTURE™ Screw System
• Version Model Number: CAPDIGITIMP
• Catalog Number: CAPDIGITIMP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780064503 [Primary]
HIBCC	M268CAPDIGITIMP1 [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

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

[M268CAPDIGITIMP1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-16
• Device Publish Date: 2015-09-22

On-Brand Devices [CAPTURE™ Screw System]

• M268CAPLOPROIMP1: The Capture Screw System is comprised of Low Profile screws used for bone fixation of the hand a
• M268CAPHLESSIMP1: The Capture Screw System is comprised of headless screws used for bone fixation of the hand and
• M268CAPDIGITIMP1: The Capture Screw System is comprised of Digital screws used for bone fixation of the hand and f
• M248CAPINSTP1: Screw System Base Instruments