NILE™ Alternative Fixation System 2601-90027

GUDID 10888857034877

Ratcheting T Handle, Square Drive

K2M, INC.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

• Primary Device ID: 10888857034877
• NIH Device Record Key: 21235b08-f625-46af-975c-571b14709d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NILE™ Alternative Fixation System
• Version Model Number: 2601-90027
• Catalog Number: 2601-90027
• Company DUNS: 146060863
• Company Name: K2M, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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(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	10888857034877 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

[10888857034877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-14
• Device Publish Date: 2021-04-06

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