NILE™ Alternative Fixation System 5401-84500-G2

GUDID 10888857269071

Clamp Assembly Size Ø4.5 mm

K2M, INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 10888857269071
• NIH Device Record Key: de75c45b-99b1-46dd-911b-25dbbab5483c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NILE™ Alternative Fixation System
• Version Model Number: 5401-84500-G2
• Catalog Number: 5401-84500-G2
• 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: true
• 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
• 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 Dimensions

• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter
• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857269071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160208

FDA Product Code

• OWI: Bone fixation cerclage, sublaminar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-16

On-Brand Devices [NILE™ Alternative Fixation System]

• 10888857269101: Clamp Assembly Size Ø5.5 mm Rail
• 10888857269095: Clamp Assembly Size Ø5.5 mm
• 10888857269088: Clamp Assembly Size Ø4.5 mm Rail / Ø6.0 mm
• 10888857269071: Clamp Assembly Size Ø4.5 mm
• 10888857157699: Clamp Assembly
• 10888857157682: Clamp Assembly
• 10888857156371: Tensioner, Size 60 mm
• 10888857156364: Tensioner, Size 30 mm
• 10888857111608: Clamp Assembly
• 10888857111592: Clamp Assembly
• 10888857000025: Band
• 10888857000018: Band
• 10888857034877: Ratcheting T Handle, Square Drive
• 10888857581852: Tensioner