Navigated Spine Instruments PRO-1027-04

GUDID 10888857549395

Navigated Awl Tap Size Ø5.5 mm

K2M, INC.

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 10888857549395
• NIH Device Record Key: df8ca1ab-00ef-4f6c-a0ad-d148e4a0bd0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Spine Instruments
• Version Model Number: PRO-1027-04
• Catalog Number: PRO-1027-04
• 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
• Phone: +1(571)919-2000
• Email: mark.zellers@stryker.com

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857549395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203205

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

[10888857549395]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-01-05

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• 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