K2M Fenestrated Tap System 5001-90015

GUDID 10888857183124

Tap, Fenestrated, Size Ø6.5 mm

K2M, INC.

Internal spinal fixation procedure kit, single-use

• Primary Device ID: 10888857183124
• NIH Device Record Key: 22cfc4bb-e377-4541-8476-43bf68abf3da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K2M Fenestrated Tap System
• Version Model Number: 5001-90015
• Catalog Number: 5001-90015
• 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	10888857183124 [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

[10888857183124]

Moist Heat or Steam Sterilization

[10888857183124]

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]

• 10888857183148: Tap, Fenestrated, Size Ø8.5 mm
• 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