Navigated Spine Instruments PRO-1108

GUDID 10888857528284

Locking Screw Inserter

K2M, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857528284
• NIH Device Record Key: bad2af55-04dd-4f28-b674-7175dcaeadde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Spine Instruments
• Version Model Number: PRO-1108
• Catalog Number: PRO-1108
• 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(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	10888857528284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201006

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10888857528284]

Moist Heat or Steam Sterilization

[10888857528284]

Moist Heat or Steam Sterilization

[10888857528284]

Moist Heat or Steam Sterilization

[10888857528284]

Moist Heat or Steam Sterilization

[10888857528284]

Moist Heat or Steam Sterilization

[10888857528284]

Moist Heat or Steam Sterilization

[10888857528284]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [Navigated Spine Instruments]

• 10888857514980: Navigation Dilator 2
• 10888857514799: Navigated Screw Inserter, Everest XT
• 10888857514782: Navigated Screw Inserter, Yukon
• 10888857488106: Navigated Screw Inserter, Mesa 2
• 10888857488090: Navigated Screw Inserter, Everest MI
• 10888857488083: Navigated Screw Inserter, Everest Locking
• 10888857481145: Navigated Cervical Taps, 5.0 mm Yukon
• 10888857481138: Navigated Cervical Taps, 4.5 mm Yukon
• 10888857481121: Navigated Cervical Taps, 4.0 mm Yukon
• 10888857481114: Navigated Cervical Taps, 3.5 mm Yukon
• 10888857481107: Navigated Cervical Taps, 3.0 mm Yukon
• 10888857481091: Navigated Awl Taps, 7.0 mm Mesa 2
• 10888857481084: Navigated Awl Taps, 12.5 mm Mesa 2
• 10888857481077: Navigated Awl Taps, 11.5 mm Mesa 2
• 10888857481060: Navigated Awl Taps, 10.5 mm Mesa 2
• 10888857481053: Navigated Awl Taps, 9.5 mm Mesa 2
• 10888857481046: Navigated Awl Taps, 8.5 mm Mesa 2
• 10888857481039: Navigated Awl Taps, 7.5 mm Mesa 2
• 10888857481022: Navigated Awl Taps, 6.5 mm Mesa 2
• 10888857481015: Navigated Awl Taps, 6.0 mm Mesa 2
• 10888857481008: Navigated Awl Taps, 5.5 mm Mesa 2
• 10888857480995: Navigated Awl Taps, 5.0 mm Mesa 2
• 10888857480988: Navigated Awl Taps, 4.5 mm Mesa 2
• 10888857480971: Navigated Awl Taps, 4.0 mm Mesa 2
• 10888857480964: Navigated Awl Taps, 3.5 mm Mesa 2
• 10888857480957: Navigated Cannulated Taps, 8.5 mm Everest MI/XT
• 10888857480940: Navigated Cannulated Taps, 7.5 mm Everest MI/XT
• 10888857480933: Navigated Cannulated Taps, 6.5 mm Everest MI/XT
• 10888857480926: Navigated Cannulated Taps, 5.5 mm Everest MI/XT
• 10888857480919: Navigated Cannulated Taps, 4.5 mm Everest MI/XT
• 10888857480902: Navigated Cannulated Taps, 4.0 mm Everest MI/XT
• 10888857480896: Navigated Awl Taps, 8.5 mm Everest
• 10888857480889: Navigated Awl Taps, 7.5 mm Everest
• 10888857480872: Navigated Awl Taps, 6.5 mm Everest
• 10888857480865: Navigated Awl Taps, 5.5 mm Everest
• 10888857480858: Navigated Awl Taps, 4.5 mm Everest
• 10888857480841: Navigated Awl Taps, 3.5 mm Everest
• 10888857515642: Navigated Drill Bit 2.8 mm
• 10888857515635: Navigated Drill Bit 2.3 mm
• 10888857528284: Locking Screw Inserter
• 10888857549418: Navigated Awl Tap Size Ø7.5 mm
• 10888857549401: Navigated Awl Tap Size Ø6.5 mm
• 10888857549395: Navigated Awl Tap Size Ø5.5 mm
• 10888857549388: Navigated Awl Tap Size Ø5.0 mm
• 10888857549371: Navigated Awl Tap Size Ø4.5 mm
• 10888857549364: Navigated Awl Tap Size Ø4.0 mm