SAHARA™ Stabilization System 5808-90002

GUDID 10888857198586

Torque Handle Size 6 in-lbs (0.7 N-m)

K2M, INC.

Surgical instrument handle, torque-limiting

• Primary Device ID: 10888857198586
• NIH Device Record Key: 51e4687a-97ef-4992-8e34-c6d4eb4ef208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAHARA™ Stabilization System
• Version Model Number: 5808-90002
• Catalog Number: 5808-90002
• Company DUNS: 146060863
• Company Name: K2M, 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: 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

Customer Support Contacts

• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857198586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151481

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[10888857198586]

Moist Heat or Steam Sterilization

[10888857198586]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-05-20

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• 10888857213753: Expandable ALIF, Size 24x30x20 mm, 5°
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• 10888857213579: Expandable ALIF, Size 24x30x18 mm, 5°
• 10888857213562: Expandable ALIF, Size 24x30x18 mm, 15°
• 10888857213555: Expandable ALIF, Size 24x30x18 mm, 10°
• 10888857213548: Expandable ALIF Size 30x40x17 mm, 5°
• 10888857213531: Expandable ALIF Size 30x40x17 mm, 15°
• 10888857213524: Expandable ALIF Size 30x40x17 mm, 10°
• 10888857213517: Expandable ALIF Size 28x36x17 mm, 5°
• 10888857213500: Expandable ALIF Size 28x36x17 mm, 15°
• 10888857213494: Expandable ALIF Size 28x36x17 mm, 10°
• 10888857213487: Expandable ALIF Size 24x30x17 mm, 5°
• 10888857213470: Expandable ALIF Size 24x30x17 mm, 15°
• 10888857213463: Expandable ALIF Size 24x30x17 mm, 10°
• 10888857213456: Expandable ALIF, Size 30x40x16 mm, 5°
• 10888857213449: Expandable ALIF Size 30x40x16 mm, 15°
• 10888857213432: Expandable ALIF, Size 30x40x16 mm, 10°
• 10888857213425: Expandable ALIF, Size 28x36x16 mm, 5°
• 10888857213418: Expandable ALIF Size 28x36x16 mm, 15°
• 10888857213401: Expandable ALIF, Size 28x36x16 mm, 10°
• 10888857213395: Expandable ALIF, Size 24x30x16 mm, 5°
• 10888857213388: Expandable ALIF Size 24x30x16 mm, 15°
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• 10888857213364: Expandable ALIF Size 30x40x15 mm, 5°
• 10888857213357: Expandable ALIF Size 30x40x15 mm, 10°