ALEUTIAN® Interbody Systems 602-90639

GUDID 10888857119284

T-Handle Inserter, Inner Shaft, Size 8.5 mm

K2M, INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10888857119284
• NIH Device Record Key: 12f47b7a-db64-410c-ada3-975afafaffb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALEUTIAN® Interbody Systems
• Version Model Number: 602-90639
• Catalog Number: 602-90639
• 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: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(703)777-3155
• Email: sgilbert@k2m.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Dimensions

• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter
• Width: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857119284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133614

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

Moist Heat or Steam Sterilization

[10888857119284]

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: 2016-09-16

On-Brand Devices [ALEUTIAN® Interbody Systems]

• 10888857430914: Cervical Inserter, Size 16 mm
• 10888857430907: Cervical Inserter, Size 14 mm
• 10888857429734: Angled Lateral Inserter, 40°
• 10888857421080: Angled Lateral Inserter, 25°
• 10888857415959: Trial, Size 0
• 10888857399136: Lateral Inserter Inner Shaft
• 10888857388659: Horseshoe, Threaded Inserter,
• 10888857381506: Cervical Inserter
• 10888857352711: Cervical Inserter, Size 16 mm
• 10888857347311: Inserter, Large Handle
• 10888857328747: Inserter, Size 11x14 mm
• 10888857328679: Inserter, Size 11x11 mm
• 10888857308084: Parallel Rasp, Size 18x45x19 mm
• 10888857308077: Parallel Rasp, Size 18x45x18 mm
• 10888857308060: Parallel Rasp, Size 18x45x17 mm
• 10888857308053: Parallel Rasp, Size 18x45x16 mm
• 10888857308046: Parallel Rasp, Size 18x45x15 mm
• 10888857308039: Parallel Rasp, Size 18x45x14 mm
• 10888857308022: Parallel Rasp, Size 18x45x13 mm
• 10888857308015: Parallel Rasp, Size 18x45x12 mm
• 10888857308008: Parallel Rasp, Size 18x45x11 mm
• 10888857307995: Parallel Rasp, Size 18x45x10 mm
• 10888857307988: Parallel Rasp, Size 18x45x9 mm
• 10888857307971: Parallel Rasp, Size 18x45x8 mm
• 10888857307964: Parallel Rasp, Size 18x45x7 mm
• 10888857307957: Parallel Rasp, Size 18x45x6 mm
• 10888857251144: Lateral Inserter
• 10888857250970: Lateral Inserter
• 10888857250321: Convex Trial, Size 17x12x32 mm
• 10888857250314: Convex Trial, Size 15x12x32 mm
• 10888857250307: Convex Trial, Size 14x12x32 mm
• 10888857250291: Convex Trial, Size 13x12x32 mm
• 10888857250284: Convex Trial, Size 12x12x32 mm
• 10888857250277: Convex Trial, Size 11x12x32 mm
• 10888857250260: Convex Trial, Size 10x12x32 mm
• 10888857250253: Convex Trial, Size 9x12x32 mm
• 10888857250246: Convex Trial, Size 8x12x32 mm
• 10888857250239: Convex Trial, Size 7x12x32 mm
• 10888857250222: Convex Trial, Size 6x12x32 mm
• 10888857250215: Convex Trial, Size 5x12x32 mm
• 10888857184589: Lordotic Trial, Size 28x36x21 mm, 10°
• 10888857184572: Lordotic Trial, Size 28x36x19 mm, 10°
• 10888857184565: Lordotic Trial, Size 28x36x17 mm, 10°
• 10888857184558: Lordotic Trial, Size 28x36x15 mm, 10°
• 10888857184541: Lordotic Trial, Size 28x36x13 mm, 10°
• 10888857184534: Lordotic Trial, Size 28x36x11 mm, 10°
• 10888857184527: Lordotic Trial, Size 28x36x9 mm, 10°
• 10888857184510: Lordotic Trial, Size 24x30x21 mm, 10°
• 10888857184503: Lordotic Trial, Size 24x30x19 mm, 10°
• 10888857184497: Lordotic Trial, Size 24x30x17 mm, 10°