Tsolution One Surgical System

GUDID M9461005730

CT MOTION ROD 30

THINK SURGICAL, INC.

Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system Robotic surgical arm system
Primary Device IDM9461005730
NIH Device Record Key2bd56762-a177-47db-8976-eea26a859b5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTsolution One Surgical System
Version Model Number100573
Company DUNS007211430
Company NameTHINK SURGICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com
Phone+1(510)249-2323
Emailgprendergast@thinksurgical.com

Device Dimensions

Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch
Length30 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9461005730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-19
Device Publish Date2016-09-24

On-Brand Devices [Tsolution One Surgical System]

M9461082000ASSEMBLY, TCAT™ 200, 100-240V
M9461076660REAMER DRIVER, ACETABULAR CUP, 001
M9461076650REAMER DRIVER SLEEVE
M9461076500BEARING SLEEVE, IMPACTOR
M9461076490BEARING SLEEVE, REAMER DRIVER
M9461076450CUTTER DRIVE ASSEMBLY, TCAT
M9461076440REAMER/IMPACTOR HOLDER
M9461076420COUPLER, MASTER SIDE
M9461063820ASSY, PERCUTANEOUS PROBE HUB
M946106298040THREADED DIGITIZER PROBE, BALL TIP
M946106298030THREADED DIGITIZER PROBE, TAPERED TROCHAR TIP
M9461062190HOFFMAN ADAPTER ROD
M9461059340SURGERY SUPPOR KIT, THA Cup US, 10 PACKS / CARTON
M9461057170TCAT THA Instrument Kit, Cup
M9461057160WRENCH, 2.5mm HEX, 465 SS
M9461056530ASSY, BEARING SLEEVE TCAT THA
M9461049480ASSEMBLY, BMM SMART PROBE, ADJUSTABLE
M9461037250CT MOTION ROD 42
M9461035930SHORT MARKER INSTALLATION TOOL
M9461034260CUTTER MOTOR
M9461034140ASSEMBLY, SWIVEL BLOCK
M9461033840CUTTER MOTOR CABLE
M9461032050ASSEMBLY, FIXATOR ARM, STRAIGHT
M9461029400ASSEMBLY, INSTALLATION VERIFICATION TOOLS
M9461027090CUTTER DRIVER PROBE
M9461005730CT MOTION ROD 30
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