Array Guide 109101

GUDID M9461091010

THINK SURGICAL, INC.

Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable

• Primary Device ID: M9461091010
• NIH Device Record Key: 4a1ee438-7b3b-4b6e-938e-86c6e67e06a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Array Guide
• Version Model Number: 109101
• Catalog Number: 109101
• Company DUNS: 007211430
• Company Name: THINK SURGICAL, INC.
• Device Count: 1
• DM Exempt: true
• 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(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	M9461091010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230202

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

[M9461091010]

Moist Heat or Steam Sterilization

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.

• 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
• M9461090040 - Tibia Tracking Array: 2023-09-05
• M9461090050 - Digitizer: 2023-09-05