FDA.reportPublic FDA data

TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System

Primary DI
M9461100501
Brand
TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System
Company
THINK SURGICAL, INC.
Model
110050
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
K263234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K263234000TMINI Miniature Robotic SystemTHINK Surgical, Inc.2026-10-16OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9461100501PrimaryHIBCC0

Regulatory Flags#

DUNS number
007211430
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M946109900N1TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System (10ea)109900-N2026-11-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141048072Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048089Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048096Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048102Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048126Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048133Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048140Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048157Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048171Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048225Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048232Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048249Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048256Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048263Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048270Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048287Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048294Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048300Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048317Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048324Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048331Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
M946109900N1TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System (10ea)THINK SURGICAL, INC.OLO2026-11-05
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774202MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31