Digitizer 109005

GUDID M9461090050

THINK SURGICAL, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: M9461090050
• NIH Device Record Key: c50f75f4-1811-4650-8588-9043614bcbe2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digitizer
• Version Model Number: 109005
• Catalog Number: 109005
• 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: 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
• 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	M9461090050 [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

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

Moist Heat or Steam Sterilization

[M9461090050]

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.

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• 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