TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®(10ea) 109900-A

GUDID M946109900A1

THINK SURGICAL, INC.

Total knee prosthesis implantation guide-instrument kit

• Primary Device ID: M946109900A1
• NIH Device Record Key: 47e63a71-e52b-4171-9ade-4e7ea7500589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®(10ea)
• Version Model Number: 109900-A
• Catalog Number: 109900-A
• 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
• 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	M946109900A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230202

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: 2025-05-02
• Device Publish Date: 2025-04-24

Devices Manufactured by THINK SURGICAL, INC.

• M946109900A1 - TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®(10ea): 2025-05-02
• M946109900A1 - TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®(10ea): 2025-05-02
• M946109900B1 - TMINI® Guide Block Kit for Total Joint Orthopedics Klassic® Knee System (10ea): 2025-05-02
• M946109900C1 - TMINI® Guide Block Kit for Ortho Development® Balanced Knee® (10ea): 2025-05-02
• M946109900D1 - TMINI® Guide Block Kit for United® U2™ Knee (10ea): 2025-05-02
• M946109900E1 - TMINI® Guide Block Kit for Medacta® Knee System (10ea): 2025-05-02
• M946109900F1 - TMINI® Guide Block Kit for b-ONE MOBIO® Total Knee System (10ea): 2025-05-02
• M946109900G1 - TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea): 2025-05-02
• M946109900J1 - TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea): 2025-05-02