K2M Fenestrated Tap System PRO-1117-06

GUDID 10888857530096

Tap, Fenestrated Size Ø8.5

K2M, INC.

Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use Internal spinal fixation procedure kit, single-use

• Primary Device ID: 10888857530096
• NIH Device Record Key: eba6b945-9ae6-4032-9944-68ef8d3f87e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Fenestrated Tap System
• Version Model Number: PRO-1117-06
• Catalog Number: PRO-1117-06
• 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

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857530096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152872

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

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

[10888857530096]

Moist Heat or Steam Sterilization

[10888857530096]

Moist Heat or Steam Sterilization

[10888857530096]

Moist Heat or Steam Sterilization

[10888857530096]

Moist Heat or Steam Sterilization

[10888857530096]

Moist Heat or Steam Sterilization

[10888857530096]

Moist Heat or Steam Sterilization

[10888857530096]

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

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