FDA.reportPublic FDA data

Tsolution One Surgical System

Primary DI
M9461057150
Brand
Tsolution One Surgical System
Company
THINK SURGICAL, INC.
Model
105715
Device description
TPLAN 200 DESKTOP SYSTEM
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153647000TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc.2016-02-16OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9461057150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Contacts#

Phone, Email table
PhoneEmail
+1(510)249-2323gprendergast@thinksurgical.com

Regulatory Flags#

DUNS number
007211430
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9461034491CT Motion Rod, 54 inch1034491034492023-08-28
M9461037251CT Motion Rod, 42 inch1037251037252023-08-28
M9461087570TMINI™ Navigation Console1087571087572023-08-28
M9461005730Tsolution One Surgical System1005732016-09-24
M9461027090Tsolution One Surgical System1027092016-09-24
M9461029400Tsolution One Surgical System1029402016-09-24
M9461032050Tsolution One Surgical System1032052016-09-24
M9461033840Tsolution One Surgical System1033842016-09-24
M9461034140Tsolution One Surgical System1034142016-09-24
M9461034260Tsolution One Surgical System1034262016-09-24
M9461035930Tsolution One Surgical System1035932016-09-24
M9461037250Tsolution One Surgical System1037252016-09-24
M9461049480Tsolution One Surgical System1049482016-09-24
M9461056530Tsolution One Surgical System1056532016-09-24
M9461057160Tsolution One Surgical System1057162016-09-24
M9461057170Tsolution One Surgical System1057172016-09-24
M9461059340Tsolution One Surgical System1059342016-09-24
M9461062190Tsolution One Surgical System1062192016-09-24
M946106298030Tsolution One Surgical System106298-032016-09-24
M946106298040Tsolution One Surgical System106298-042016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07