T2 ALPHA 2353-3911

GUDID 07613327659436

Poller Screw Inserter, Fixation Screw

Stryker GmbH

Orthopaedic implant aiming arm

• Primary Device ID: 07613327659436
• NIH Device Record Key: 07a15b07-7437-4d89-8c89-7b721f961dab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2 ALPHA
• Version Model Number: 2353-3911
• Catalog Number: 2353-3911
• Company DUNS: 481999654
• Company Name: Stryker GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327659436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250163

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

[07613327659436]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-19

On-Brand Devices [T2 ALPHA]

• 07613327659443: Poller Screw Inserter
• 07613327659436: Poller Screw Inserter, Fixation Screw
• 07613327649079: Retrograde Crown Drill