FDA.reportPublic FDA data

Thrive Orthopedics

Primary DI
00810079192380
Brand
Thrive Orthopedics
Company
Thrive Orthopedics LLC
Model
FMSLT
Device description
F5 Medial FlexTrim Carbon Fiber AFO - Small, Left
Published
2025-11-17
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
00810079192380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810079192380008100791923808100791923800810079192380

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
00810079192656Thrive OrthopedicsFCCIM62026-05-27
00810079192663Thrive OrthopedicsFCCIM72026-05-27
00810079192670Thrive OrthopedicsFCCIM82026-05-27
00810079192687Thrive OrthopedicsFCCIM92026-05-27
00810079192694Thrive OrthopedicsFCCIM102026-05-27
00810079192700Thrive OrthopedicsFCCIM112026-05-27
00810079192717Thrive OrthopedicsFCCIM122026-05-27
00810079192724Thrive OrthopedicsFCCIM132026-05-27
00810079192731Thrive OrthopedicsFCCIM142026-05-27
00810079192748Thrive OrthopedicsCCIM62026-05-27
00810079192755Thrive OrthopedicsCCIM72026-05-27
00810079192762Thrive OrthopedicsCCIM82026-05-27
00810079192779Thrive OrthopedicsCCIM92026-05-27
00810079192786Thrive OrthopedicsCCIM102026-05-27
00810079192793Thrive OrthopedicsCCIM112026-05-27
00810079192809Thrive OrthopedicsCCIM122026-05-27
00810079192816Thrive OrthopedicsCCIM132026-05-27
00810079192823Thrive OrthopedicsCCIM142026-05-27
00810079192946Thrive OrthopedicsSFXSRT2026-05-27
00810079192953Thrive OrthopedicsSFSLT2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221358MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221365MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221372MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221389MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221396MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221402MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221419MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221426MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221433MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221440MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221457MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221464MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221471MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221488MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221495MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221501MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221563MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221570MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221587MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221594MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221600MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221617MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221624MEDIMEDI MANUFACTURING, INC.IQI2026-07-20
00636257221631MEDIMEDI MANUFACTURING, INC.IQI2026-07-20