K2M Fenestrated Tap System 5001-90017

GUDID 10888857183148

Tap, Fenestrated, Size Ø8.5 mm

K2M, INC.

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

• Primary Device ID: 10888857183148
• NIH Device Record Key: 3f2d23be-3351-487c-ae77-984197b818bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Fenestrated Tap System
• Version Model Number: 5001-90017
• Catalog Number: 5001-90017
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888857183148 [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

[10888857183148]

Moist Heat or Steam Sterilization

[10888857183148]

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

On-Brand Devices [K2M Fenestrated Tap System]

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