Tsolution One Surgical System

GUDID M9461056530

ASSY, BEARING SLEEVE TCAT THA

THINK SURGICAL, INC.

Robotic surgical arm system

• Primary Device ID: M9461056530
• NIH Device Record Key: 6f8d9d4f-295c-441c-8f01-d47279681e59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tsolution One Surgical System
• Version Model Number: 105653
• 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: 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)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com
• Phone: +1(510)249-2323
• Email: gprendergast@thinksurgical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9461056530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153647

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Tsolution One Surgical System]

• M9461082000: ASSEMBLY, TCAT™ 200, 100-240V
• M9461076660: REAMER DRIVER, ACETABULAR CUP, 001
• M9461076650: REAMER DRIVER SLEEVE
• M9461076500: BEARING SLEEVE, IMPACTOR
• M9461076490: BEARING SLEEVE, REAMER DRIVER
• M9461076450: CUTTER DRIVE ASSEMBLY, TCAT
• M9461076440: REAMER/IMPACTOR HOLDER
• M9461076420: COUPLER, MASTER SIDE
• M9461063820: ASSY, PERCUTANEOUS PROBE HUB
• M946106298040: THREADED DIGITIZER PROBE, BALL TIP
• M946106298030: THREADED DIGITIZER PROBE, TAPERED TROCHAR TIP
• M9461062190: HOFFMAN ADAPTER ROD
• M9461059340: SURGERY SUPPOR KIT, THA Cup US, 10 PACKS / CARTON
• M9461057170: TCAT THA Instrument Kit, Cup
• M9461057160: WRENCH, 2.5mm HEX, 465 SS
• M9461056530: ASSY, BEARING SLEEVE TCAT THA
• M9461049480: ASSEMBLY, BMM SMART PROBE, ADJUSTABLE
• M9461037250: CT MOTION ROD 42
• M9461035930: SHORT MARKER INSTALLATION TOOL
• M9461034260: CUTTER MOTOR
• M9461034140: ASSEMBLY, SWIVEL BLOCK
• M9461033840: CUTTER MOTOR CABLE
• M9461032050: ASSEMBLY, FIXATOR ARM, STRAIGHT
• M9461029400: ASSEMBLY, INSTALLATION VERIFICATION TOOLS
• M9461027090: CUTTER DRIVER PROBE
• M9461005730: CT MOTION ROD 30