Tahoe Unicompartmental Knee System 3610-0-0000

GUDID 00840286855969

TUKS, TIBIAL PREP GUIDE, DROP ROD ALIGNMENT, ASSY

Shalby Advanced Technologies, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00840286855969
• NIH Device Record Key: 79b1fb92-3066-4933-94fa-0cd8e17d62bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tahoe Unicompartmental Knee System
• Version Model Number: 3610-0-0000
• Catalog Number: 3610-0-0000
• Company DUNS: 085976260
• Company Name: Shalby Advanced Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com
• Phone: +1(916)355-7100
• Email: khansen@consensusortho.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840286855969 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

[00840286855969]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

On-Brand Devices [Tahoe Unicompartmental Knee System]

• 00840286846738: TUKS, Alignment Rod, 6.4mm x 15" Length
• 00840286846707: Fixation Pin, Tri-Face with Tri-Hub, OC 3.2mm, 2" Long
• 00840286855969: TUKS, TIBIAL PREP GUIDE, DROP ROD ALIGNMENT, ASSY
• 00840286855952: Pin Puller, Assy
• 00840286855945: TUKS, Instrument Case 2, Assembly
• 00840286855938: TUKS, Instrument Case 1, Assembly