FDA.reportPublic FDA data

Femur Tracking Array

Primary DI
M9461090030
Brand
Femur Tracking Array
Company
THINK SURGICAL, INC.
Model
109003
Catalog number
109003
Published
2023-08-28
Public version status
Update
Distribution status
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
K230202000
K232802000
K241031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230202000TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023-04-25OLO
K232802000TMINI™ Miniature Robotic SystemTHINK Surgical, Inc.2023-10-12OLO
K241031000TMINI Miniature Robotic System (TMINI 1.1)THINK Surgical, Inc.2024-07-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9461090030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(510)249-2300customerservice@thinksurgical.com

Regulatory Flags#

DUNS number
007211430
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
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
00810180351720360CASKICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2026-07-09
10705034647302CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647319CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647326CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647333CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647340CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647357CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647371CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647388CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647395CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647418CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647425CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647432CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647449CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647456CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647470CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647487CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647494CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647500CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647517CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647524CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647531CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647548CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647555CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647562CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647579CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647586CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647593CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
10705034647609CROSSNAV CONDUITMedos International SàrlOLO2026-07-09