K2M Fenestrated Tap System 5001-90013

GUDID 10888857183100

Tap, Fenestrated, Size Ø4.5 mm

K2M, INC.

Internal spinal fixation procedure kit, single-use

• Primary Device ID: 10888857183100
• NIH Device Record Key: 062b9383-a8f1-4a57-a3cb-559acf38787f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Fenestrated Tap System
• Version Model Number: 5001-90013
• Catalog Number: 5001-90013
• 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(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• Phone: +1(703)777-3155
• Email: mzellers@k2m.com
• 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	10888857183100 [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

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

[10888857183100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-10-24

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• 10888857530041: Tap, Fenestrated Size Ø4.0
• 10888857183087: Fenestrated Tap Adapter Quick Connect