ALEUTIAN Interbody Systems SP-2477-04

GUDID 10888857394117

Lordotic Angled Trial, Size 20x60x5 mm, 8°

K2M, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857394117
• NIH Device Record Key: 3336b72f-525b-4e25-8e76-62a2109abc48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALEUTIAN Interbody Systems
• Version Model Number: SP-2477-04
• Catalog Number: SP-2477-04
• 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
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857394117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133614

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

[10888857394117]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-26

On-Brand Devices [ALEUTIAN Interbody Systems]

• 10888857394162: Parallel Angled Trial, Size 20x60x7 mm
• 10888857394155: Parallel Angled Trial, Size 20x60x6 mm
• 10888857394148: Parallel Angled Trial, Size 20x60x5 mm
• 10888857394131: Lordotic Angled Trial, Size 20x60x7 mm, 8°
• 10888857394124: Lordotic Angled Trial, Size 20x60x6 mm, 8°
• 10888857394117: Lordotic Angled Trial, Size 20x60x5 mm, 8°
• 10888857391765: Lordotic Trial, Size 20x60x7 mm, 8°
• 10888857391758: Lordotic Trial, Size 20x60x6 mm, 8°
• 10888857391741: Lordotic Trial, Size 20x60x5 mm, 8°
• 10888857390379: Parallel Trial, Size 20x60x7 mm
• 10888857390362: Parallel Trial, Size 20x60x6 mm
• 10888857390355: Parallel Trial, Size 20x60x5 mm
• 10888857189324: Angled Lateral Inserter Driver
• 10888857189256: 22 mm Lateral Box Chisel Size 15 mm
• 10888857189232: 22 mm Lateral Box Chisel Size 13 mm
• 10888857189218: 22 mm Lateral Box Chisel Size 11 mm
• 10888857189195: 22 mm Lateral Box Chisel Size 9 mm
• 10888857189171: 22 mm Lateral Box Chisel Size 7 mm
• 10888857189157: 22 mm Lateral Box Chisel Size 5 mm
• 10888857189140: 22 mm Lateral Box Chisel Size 4 mm
• 10888857189089: 18 mm Lateral Box Chisel Size 15 mm
• 10888857189065: 18 mm Lateral Box Chisel Size 13 mm
• 10888857189041: 18 mm Lateral Box Chisel Size 11 mm
• 10888857189027: 18 mm Lateral Box Chisel Size 9 mm
• 10888857189003: 18 mm Lateral Box Chisel Size 7 mm
• 10888857188983: 18 mm Lateral Box Chisel Size 5 mm
• 10888857188976: 18 mm Lateral Box Chisel Size 4 mm
• 10888857188969: Lordotic Angled Trial Size 22x60x16 mm
• 10888857188921: Lordotic Angled Trial Size 22x60x14 mm
• 10888857188884: Lordotic Angled Trial Size 22x60x12 mm
• 10888857188846: Lordotic Angled Trial Size 22x60x10 mm
• 10888857188808: Lordotic Angled Trial Size 22x60x8 mm
• 10888857188785: Parallel Angled Trial Size 22x60x16 mm
• 10888857188761: Parallel Angled Trial Size 22x60x14 mm
• 10888857188723: Parallel Angled Trial Size 22x60x12 mm
• 10888857188686: Parallel Angled Trial Size 22x60x10 mm
• 10888857188648: Parallel Angled Trial Size 22x60x8 mm
• 10888857188600: Lordotic Angled Trial Size 18x60x16 mm
• 10888857188563: Lordotic Angled Trial Size 18x60x14 mm
• 10888857188525: Lordotic Angled Trial Size 18x60x12 mm
• 10888857188488: Lordotic Angled Trial Size 18x60x10 mm
• 10888857188440: Lordotic Angled Trial Size 18x60x8 mm
• 10888857188402: Parallel Angled Trial Size 18x60x16 mm
• 10888857188365: Parallel Angled Trial Size 18x60x14 mm
• 10888857188327: Parallel Angled Trial Size 18x60x12 mm
• 10888857188280: Parallel Angled Trial Size 18x60x10 mm
• 10888857188242: Parallel Angled Trial Size 18x60x8 mm
• 10888857188204: Slap Hammer Adapter
• 10888857188181: Trial Handle
• 10888857188174: Slap Hammer