T2, PANGEA 543170

GUDID 07613327649130

Strut Inserter, Lateral, R

Stryker GmbH

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: 07613327649130
• NIH Device Record Key: 8b8bf11f-0e7d-498d-925e-1b08d15e4ee7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2, PANGEA
• Version Model Number: 543170
• Catalog Number: 543170
• 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 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327649130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250163

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

[07613327649130]

Moist Heat or Steam Sterilization

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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• 07613327649758: AlphaLink Dowel
• 07613327649741: AlphaLink Dowel
• 07613327649734: AlphaLink Dowel
• 07613327649727: AlphaLink Dowel
• 07613327649703: AlphaLink Dowel
• 07613327649697: Distal Medial Femur Strut, R
• 07613327649673: Distal Medial Femur Strut, R
• 07613327649666: Distal Medial Femur Strut, R
• 07613327649659: Distal Medial Femur Strut, R
• 07613327649642: Distal Lateral Femur Strut, R
• 07613327649635: Distal Medial Femur Strut, L
• 07613327649628: Distal Lateral Femur Strut, R
• 07613327649611: Distal Medial Femur Strut, L
• 07613327649604: Distal Medial Femur Strut, L
• 07613327649598: Distal Medial Femur Strut, L
• 07613327649581: Distal Lateral Femur Strut, R
• 07613327649574: Distal Lateral Femur Strut, R
• 07613327649567: Distal Lateral Femur Strut, R
• 07613327649550: Distal Lateral Femur Strut, R
• 07613327649543: Distal Lateral Femur Strut, R
• 07613327649536: Distal Lateral Femur Strut, R
• 07613327649529: Distal Lateral Femur Strut, R
• 07613327649512: Distal Lateral Femur Strut, R
• 07613327649505: Distal Lateral Femur Strut, R
• 07613327649499: Distal Lateral Femur Strut, R
• 07613327649482: Distal Lateral Femur Strut, R
• 07613327649475: Distal Lateral Femur Strut, R
• 07613327649468: Distal Lateral Femur Strut, R
• 07613327649451: Distal Lateral Femur Strut, L
• 07613327649444: Distal Lateral Femur Strut, R
• 07613327649437: Distal Lateral Femur Strut, R
• 07613327649420: Distal Lateral Femur Strut, R
• 07613327649413: Distal Lateral Femur Strut, L,
• 07613327649406: Distal Lateral Femur Strut, L
• 07613327649390: Distal Lateral Femur Strut, L
• 07613327649383: Distal Lateral Femur Strut, L
• 07613327649376: Distal Lateral Femur Strut, L
• 07613327649369: Distal Lateral Femur Strut, L
• 07613327649352: Distal Lateral Femur Strut, L
• 07613327649345: Distal Lateral Femur Strut, L
• 07613327649338: Distal Lateral Femur Strut, L
• 07613327649321: Distal Lateral Femur Strut, L
• 07613327649314: Distal Lateral Femur Strut, L
• 07613327649307: Distal Lateral Femur Strut, L
• 07613327649291: Distal Lateral Femur Strut, L
• 07613327649284: Distal Lateral Femur Strut, L