Nakoma 3100T-1400

GUDID M6863100T14000

Fixed Single Barrel Drill Guide Instrument

ALLIANCE PARTNERS LLC

Surgical drill guide, reusable

• Primary Device ID: M6863100T14000
• NIH Device Record Key: f14df071-6597-4dbd-af69-50056f138ceb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nakoma
• Version Model Number: 3100T-1400
• Catalog Number: 3100T-1400
• Company DUNS: 962768169
• Company Name: ALLIANCE PARTNERS LLC
• 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: false
• 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(210)314-2525
• Email: info@alliance-spine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M6863100T14000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141993

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[M6863100T14000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Nakoma]

• M6863100T16000: Fixed Double Barrel Drill Guide Instrument
• M6863100T14000: Fixed Single Barrel Drill Guide Instrument
• M6863100T11000: Plate Holder Instrument
• M6863100T21000: Bone Awl Instrument
• M6863100T17000: Tap Instrument