FDA.reportPublic FDA data

Tsolution One Surgical System

Primary DI
M9461059340
Brand
Tsolution One Surgical System
Company
THINK SURGICAL, INC.
Model
105934
Device description
SURGERY SUPPOR KIT, THA Cup US, 10 PACKS / CARTON
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
Single use
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
M9461059340PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
007211430
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
M9461062190Tsolution One Surgical System1062192016-09-24
M946106298030Tsolution One Surgical System106298-032016-09-24
M946106298040Tsolution One Surgical System106298-042016-09-24
M9461063820Tsolution One Surgical System1063822016-09-24

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