Nakoma 3100T-2100

GUDID M6863100T21000

Bone Awl Instrument

ALLIANCE PARTNERS LLC

Bone awl, reusable

• Primary Device ID: M6863100T21000
• NIH Device Record Key: defb3ec1-16f9-4742-bdbe-a4fe197a5b53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nakoma
• Version Model Number: 3100T-2100
• Catalog Number: 3100T-2100
• 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
• Phone: +1(210)314-2525
• Email: info@alliance-spine.com
• Phone: +1(210)314-2525
• Email: info@alliance-spine.com
• Phone: +1(210)314-2525
• Email: info@alliance-spine.com
• Phone: +1(210)314-2525
• Email: info@alliance-spine.com
• Phone: +1(210)314-2525
• Email: info@alliance-spine.com

Device Dimensions

• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter
• Outer Diameter: 2.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M6863100T21000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141993

FDA Product Code

• HWJ: AWL

Sterilization

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

[M6863100T21000]

Moist Heat or Steam Sterilization

[M6863100T21000]

Moist Heat or Steam Sterilization

[M6863100T21000]

Moist Heat or Steam Sterilization

[M6863100T21000]

Moist Heat or Steam Sterilization

[M6863100T21000]

Moist Heat or Steam Sterilization

[M6863100T21000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• 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