T2, PANGEA 6497-1-090S

GUDID 07613327649321

Distal Lateral Femur Strut, L

Stryker GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 07613327649321
• NIH Device Record Key: c935624c-b10e-426b-a8a0-359433c0e559
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2, PANGEA
• Version Model Number: 6497-1-090S
• Catalog Number: 6497-1-090S
• Company DUNS: 481999654
• Company Name: Stryker GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 328 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327649321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250163

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

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• 07613327649703: AlphaLink Dowel
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• 07613327649635: Distal Medial Femur Strut, L
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