CHESAPEAKE® Stabilization System 3608-213153

GUDID 10888857082144

3-Screw Titanium Implant, Size 15x18x13 mm

K2M, INC.

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10888857082144
• NIH Device Record Key: 7aa55369-f343-4de6-9ca3-b99c262661cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHESAPEAKE® Stabilization System
• Version Model Number: 3608-213153
• Catalog Number: 3608-213153
• 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: true
• 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

Device Dimensions

• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Height: 13 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857082144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111439

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

[10888857082144]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-10

On-Brand Devices [CHESAPEAKE® Stabilization System]

• 10888857404403: T-Handle Tightener
• 10888857404397: Inner Shaft
• 10888857404380: Implant Inserter
• 10888857385795: Single Barrel Drill Guide
• 10888857381537: Adjustable Inserter
• 10888857320895: Modular Anterior Insertion Ramp, Size Insertion Ramp
• 10888857295902: Drill Guide, Size 8 mm
• 10888857295896: Drill Guide, Size 7 mm
• 10888857271371: Screw, Self Starting, Size Ø5.5x35 mm
• 10888857271364: Screw, Self Starting, Size Ø5.5x15 mm
• 10888857271357: Screw, Self Starting, Size Ø5.5x30 mm
• 10888857271340: Screw, Self Starting, Size Ø5.5x25 mm
• 10888857271333: Screw, Self Starting, Size Ø5.5x20 mm
• 10888857243453: Drill Guide Inserter
• 10888857198579: Removal Tool
• 10888857181274: Expandable Drill Guide, Size 21 mm
• 10888857181267: Expandable Drill Guide, Size 19 mm
• 10888857181250: Expandable Drill Guide, Size 17 mm
• 10888857181243: Expandable Drill Guide, Size 15 mm
• 10888857181236: Expandable Drill Guide, Size 13 mm
• 10888857181229: Expandable Drill Guide, Size 11 mm
• 10888857157248: Implant
• 10888857157231: Implant
• 10888857157224: Implant
• 10888857157217: Implant, Size 28x36x21 mm, 30°
• 10888857157200: Implant, Size 28x36x21 mm, 25°
• 10888857157194: Implant, Size 28x36x21 mm, 20°
• 10888857157187: Implant, Size 30x40x20 mm, 30°
• 10888857157170: Implant, Size 30x40x20 mm, 25°
• 10888857157163: Implant, Size 30x40x20 mm, 20°
• 10888857157156: Implant, Size 28x36x20 mm, 30°
• 10888857157149: Implant, Size 28x36x20 mm, 25°
• 10888857157132: Implant, Size 28x36x20 mm, 20°
• 10888857157125: Implant
• 10888857157118: Implant
• 10888857157101: Implant
• 10888857157095: Implant
• 10888857157088: Implant
• 10888857157071: Implant
• 10888857157064: Implant, Size 30x40x18 mm, 30°
• 10888857157057: Implant, Size 30x40x18 mm, 25°
• 10888857157040: Implant, Size 30x40x18 mm, 20°
• 10888857157033: Implant, Size 28x36x18 mm, 30°
• 10888857157026: Implant, Size 28x36x18 mm, 25°
• 10888857157019: Implant, Size 28x36x18 mm, 20°
• 10888857157002: Implant
• 10888857156999: Implant
• 10888857156982: Implant
• 10888857156975: Implant
• 10888857156968: Implant