K2M Fenestrated Tap System PRO-1117-04

GUDID 10888857530072

Tap, Fenestrated Size Ø6.5

K2M, INC.

Internal spinal fixation procedure kit, single-use

• Primary Device ID: 10888857530072
• NIH Device Record Key: 442fb19b-a6b4-464c-9a08-3dc40f06705a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Fenestrated Tap System
• Version Model Number: PRO-1117-04
• Catalog Number: PRO-1117-04
• 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: true
• 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
• 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: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter
• Outer Diameter: 6.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857530072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152872

FDA Product Code

• OAR: Injector, vertebroplasty (does not contain cement)

Sterilization

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

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

[10888857530072]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-16
• Device Publish Date: 2021-08-06

On-Brand Devices [K2M Fenestrated Tap System]

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• 10888857183131: Tap, Fenestrated, Size Ø7.5 mm
• 10888857183124: Tap, Fenestrated, Size Ø6.5 mm
• 10888857183117: Tap, Fenestrated, Size Ø5.5 mm
• 10888857183100: Tap, Fenestrated, Size Ø4.5 mm
• 10888857183094: Tap, Fenestrated, Size Ø4.0 mm
• 10888857461338: Tap, Fenestrated, Size Ø8.5
• 10888857461321: Tap, Fenestrated, Size Ø7.5
• 10888857461314: Tap, Fenestrated, Size Ø6.5
• 10888857461307: Tap, Fenestrated, Size Ø5.5
• 10888857461291: Tap, Fenestrated, Size Ø4.5
• 10888857461284: Tap, Fenestrated, Size Ø3.5
• 10888857530096: Tap, Fenestrated Size Ø8.5
• 10888857530089: Tap, Fenestrated Size Ø7.5
• 10888857530072: Tap, Fenestrated Size Ø6.5
• 10888857530065: Tap, Fenestrated Size Ø5.5
• 10888857530058: Tap, Fenestrated Size Ø4.5
• 10888857530041: Tap, Fenestrated Size Ø4.0
• 10888857183087: Fenestrated Tap Adapter Quick Connect