Navigation Instruments 1001-N90120-M

GUDID 10888857379374

MI Awl-Tap, Size Ø 7.5mm DENALI MI

K2M, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 10888857379374
• NIH Device Record Key: 89069278-7cd9-4f5f-a8e4-783572914c96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Instruments
• Version Model Number: 1001-N90120-M
• Catalog Number: 1001-N90120-M
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857379374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171321

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10888857379374]

Moist Heat or Steam Sterilization

[10888857379374]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-21
• Device Publish Date: 2017-09-12

On-Brand Devices [Navigation Instruments]

• 10888857384330: Polyaxial Screw Inserter, XTower
• 10888857380257: Tap, Size Ø5.5 mm MESA 2 Cortical
• 10888857380240: Tap, Size Ø5.0 mm MESA 2 Cortical
• 10888857380233: Tap, Size Ø4.5 mm MESA 2 Cortical
• 10888857380226: Tap, Size Ø4.0 mm MESA 2 Cortical
• 10888857380219: Tap, Size Ø3.5 mm MESA 2 Cortical
• 10888857380165: MESA 2 Tap, Size Ø7.0 mm
• 10888857380110: MESA 2 Tap, Size Ø8.5 mm
• 10888857380103: MESA 2 Tap, Size Ø7.5 mm
• 10888857380097: MESA 2 Tap, Size Ø6.5 mm
• 10888857380080: MESA 2 Tap, Size Ø6.0 mm
• 10888857380073: MESA 2 Tap, Size Ø5.5 mm
• 10888857380066: MESA 2 Tap, Size Ø5.0 mm
• 10888857380059: MESA 2 Tap, Size Ø4.5 mm
• 10888857380042: MESA 2 Tap, Size Ø4.0 mm
• 10888857380035: MESA 2 Tap, Size Ø3.5 mm
• 10888857379961: Locking Screw Inserter, XT, Cannulated, EVEREST XT
• 10888857379947: Tapered Thread Tap, Cannulated, Size Ø8.5 mm EVEREST MI
• 10888857379930: Tapered Thread Tap, Cannulated, Size Ø7.5 mm EVERESTMI
• 10888857379923: Tapered Thread Tap, Cannulated, Size Ø6.5 mm EVEREST MI
• 10888857379916: Tapered Thread Tap, Cannulated, Size Ø5.5 mm EVEREST MI
• 10888857379909: Tapered Thread Tap, Cannulated, Size Ø4.5 mm EVEREST MI
• 10888857379893: Tapered Thread Tap, Cannulated, Size Ø4.0 mm EVEREST MI
• 10888857379886: Cannulated Screw Inserter, EVEREST MI
• 10888857379879: Tap, Size Ø7.5 mm MESA Small Stature
• 10888857379862: Tap, Size Ø6.5 mm MESA Small Stature
• 10888857379855: Tap, Size Ø5.5 mm MESA Small Stature
• 10888857379848: Tap, Size Ø5.0 mm MESA Small Stature
• 10888857379831: Tap, Size Ø4.5 mm MESA Small Stature
• 10888857379824: Tap, Size Ø4.0 mm MESA Small Stature
• 10888857379817: Tap, Size Ø3.5 mm MESA Small Stature
• 10888857379800: Tap, Size Ø3.0 mm MESA Small Stature
• 10888857379794: Screw Inserter, MESA Small Stature
• 10888857379718: Awl Tap, Size Ø8.5 mm EVEREST
• 10888857379701: Awl Tap, Size Ø7.5 mm EVEREST
• 10888857379695: Awl Tap, Size Ø6.5 mm EVEREST
• 10888857379688: Awl Tap, Size Ø5.5 mm EVEREST
• 10888857379671: Awl Tap, Size Ø4.5 mm EVEREST
• 10888857379664: Awl Tap, Size Ø3.5 mm EVEREST
• 10888857379657: Tapered Tap, Size 8.5 mm EVEREST
• 10888857379640: Tapered Tap, Size 7.5 mm EVEREST
• 10888857379633: Tapered Tap, Size 6.5 mm EVEREST
• 10888857379626: Tapered Tap, Size 5.5 mm EVEREST
• 10888857379619: Tapered Tap, Size 4.5 mm EVEREST
• 10888857379602: Tapered Tap, Size 3.5 mm EVEREST
• 10888857379596: Polyaxial Screw Inserter, EVEREST
• 10888857379589: Awl Tap, Size Ø7.5 mm EVEREST
• 10888857379572: Awl Tap, Size Ø6.5 mm EVEREST
• 10888857379565: Awl Tap, Size Ø5.5 mm EVEREST
• 10888857379558: Awl Tap, Size Ø4.5 mm EVEREST