FDA.reportPublic FDA data

Thrive Orthopedics

Primary DI
00810079191543
Brand
Thrive Orthopedics
Company
Thrive Orthopedics LLC
Model
MSLT-MAG
Device description
F5 Magnetic Medial Carbon Fiber AFO - Small, Left
Published
2023-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IQIOrthosis, Limb Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810079191543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810079191543008100791915438100791915430810079191543

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035286635
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810079192939Thrive OrthopedicsSFXSLT2026-05-21
00810079192144Thrive OrthopedicsIQ-10032025-11-24
00810079192151Thrive OrthopedicsIQ-10042025-11-24
00810079191918Thrive OrthopedicsUFOLT-MAG2025-11-17
00810079191925Thrive OrthopedicsUFORT-MAG2025-11-17
00810079192311Thrive OrthopedicsFSMRT-MAG2025-11-17
00810079192328Thrive OrthopedicsFSLLT-MAG2025-11-17
00810079192359Thrive OrthopedicsFSXLRT-MAG2025-11-17
00810079192366Thrive OrthopedicsFMXSLT2025-11-17
00810079192373Thrive OrthopedicsFMXSRT2025-11-17
00810079192380Thrive OrthopedicsFMSLT2025-11-17
00810079192397Thrive OrthopedicsFMSRT2025-11-17
00810079192403Thrive OrthopedicsFMMLT2025-11-17
00810079192410Thrive OrthopedicsFMMRT2025-11-17
00810079192427Thrive OrthopedicsFMLLT2025-11-17
00810079192434Thrive OrthopedicsFMLRT2025-11-17
00810079192441Thrive OrthopedicsFMXLLT2025-11-17
00810079192458Thrive OrthopedicsFMXLRT2025-11-17
00810079192465Thrive OrthopedicsFMXSLT-MAG2025-11-17
00810079192472Thrive OrthopedicsFMXSRT-MAG2025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257213322MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213339MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213353MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213360MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213377MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213384MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00636257213391MEDIMEDI MANUFACTURING, INC.IQI2026-04-24
00645517899312TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899329TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899336TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899343TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899398TrulifeTRULIFE LIMITEDIQI2026-04-22
00645517899404TrulifeTRULIFE LIMITEDIQI2026-04-22
00810075281620BoneFoamBONE FOAM, INC.IQI2025-08-15
10841156111298ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
10841156111304ACCUMEDTELEFLEX INCORPORATEDIQI2025-03-11
00810079190102Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190119Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190126Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190133Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190140Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190157Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190164Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079190171Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191703The Equinus BraceThrive Orthopedics LLCIQI2024-12-10
00810079191710Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191727Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191734Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10
00810079191741Thrive OrthopedicsThrive Orthopedics LLCIQI2024-12-10