Chesapeake Stabilization System SP-3018

GUDID 10888857404472

Anti Torque Handle

K2M, INC.

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• Primary Device ID: 10888857404472
• NIH Device Record Key: fa7ad461-ae13-4272-af5f-1cb55f516a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chesapeake Stabilization System
• Version Model Number: SP-3018
• Catalog Number: SP-3018
• 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(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• 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
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857404472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133494

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

[10888857404472]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-31

On-Brand Devices [Chesapeake Stabilization System]

• 10888857404472: Anti Torque Handle
• 10888857083264: Implant Inserter, Adjustable Stops
• 10888857083011: Ø3.5 mm Universal Drill, Screw Ø3.5x14 mm Screw
• 10888857083004: Universal Awl
• 10888857082977: Non-Tapered Universal Driver Size 10
• 10888857082960: Universal Tapered Driver Size 10
• 10888857082953: Universal Tap/Screw Ø3.5x14 mm Screw
• 10888857082823: Inner Shaft, Threaded
• 10888857082793: Single Barrel Drill/Screw Ø3.5x12 mm Screw
• 10888857082779: Ø3.5 mm Drill, Screw Ø3.5x14 mm Screw
• 10888857082762: Tap/Screw Ø3.5x14 mm Screw
• 10888857082625: Non-Tapered Driver Size 10
• 10888857082618: Tapered Driver Size 10
• 10888857082601: Implant Pusher
• 10888857082595: Awl
• 10888857082588: Ø3.5 mm Drill, Screw
• 10888857082571: 3-Screw Drill Guide Inserter Size 10 mm
• 10888857082564: 3-Screw Drill Guide Inserter Size 9 mm
• 10888857082557: 3-Screw Drill Guide Inserter Size 8 mm
• 10888857082540: 3-Screw Drill Guide Inserter Size 7 mm
• 10888857082533: 3-Screw Drill Guide Inserter Size 6 mm
• 10888857082526: 3-Screw Drill Guide Inserter Size 5 mm
• 10888857082397: Torque Limiting Handle Size 12 in-lbs (1.4 N-m)
• 10888857182752: Universal Tapered Driver Size 20
• 10888857157712: Drill Guide, Inserter Clip
• 10888857026582: Expandable Drill Guide Size 17 mm
• 10888857026551: Expandable Drill Guide Size 11 mm
• 10888857025745: Zero Countersink Modular Tip Allograft
• 10888857025721: Zero Countersink Modular Tip Chesapeake
• 10888857025714: Universal Tap Size Ø5.25x20 mm
• 10888857025684: Universal Drill Size Ø5.5x20 mm
• 10888857025646: Awl Size 25 mm
• 10888857025639: Spring Loaded Awl Size 20 mm
• 10888857025622: Non-Tapered Driver Size 20
• 10888857025615: Torque Handle Size 20 in-lbs (2.3 N-m)
• 10888857025585: Tap Size 20 mm
• 10888857025554: Tapered Driver Size 20
• 10888857025547: Drill Size Ø5.5x20 mm
• 10888857025530: Awl Size 20 mm
• 10888857025516: Universal Awl Size 25 mm
• 10888857025509: Universal Awl Size 20 mm
• 10888857025493: Universal Tapered Driver Size 20
• 10888857025462: Modular Tip Assembly
• 10888857025455: Inner Shaft Assembly
• 10888857383494: Universal Driver Size 20
• 10888857297296: Distractor Size 21 mm
• 10888857297289: Distractor Size 19 mm
• 10888857297272: Distractor Size 17 mm
• 10888857297265: Distractor Size 15 mm
• 10888857297258: Distractor Size 13 mm