TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System® 109421

GUDID M9461094211

THINK SURGICAL, INC.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: M9461094211
• NIH Device Record Key: 15a1709c-5c7b-49e8-9750-141a662c49bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®
• Version Model Number: 109421
• Catalog Number: 109421
• Company DUNS: 007211430
• Company Name: THINK SURGICAL, 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: true
• 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(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com
• Phone: +1(510)249-2300
• Email: customerservice@thinksurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9461094211 [Primary]

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-05
• Device Publish Date: 2023-08-28

Devices Manufactured by THINK SURGICAL, INC.

• M9461094221 - TMINI™ Guide Block Kit for U2™ Knee Total Knee System: 2024-08-09
• M9461094811 - TMINI™ Guide Block Kit for BKS® and BKS TriMax® Knee System: 2024-08-09
• M9461034491 - CT Motion Rod, 54 inch: 2023-09-05
• M9461037251 - CT Motion Rod, 42 inch: 2023-09-05
• M9461069270 - Universal Cut Block: 2023-09-05
• M9461087570 - TMINI™ Navigation Console: 2023-09-05
• M9461090000 - TPLAN® Planning Station: 2023-09-05
• M9461090030 - Femur Tracking Array: 2023-09-05