TPLAN® Planning Station 109000

GUDID M9461090000

THINK SURGICAL, INC.

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• Primary Device ID: M9461090000
• NIH Device Record Key: 1ec6faaf-4511-4d3d-8498-abc215b79ba5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPLAN® Planning Station
• Version Model Number: 109000
• Catalog Number: 109000
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	M9461090000 [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: false

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
• 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