FDA.reportPublic FDA data

Stat-A-Dyne Ankle

Primary DI
B770AN0
Brand
Stat-A-Dyne Ankle
Company
LANTZ MEDICAL, INC.
Model
Ankle
Device description
Orthosis providing flexion and extension of ankle
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
B770AN0PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
614335276
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B770WR0Stat-A-Dyne WristWristWrist2023-06-07
B770EL0Stat-A-Dyne ElbowElbowElbow2022-12-08
B770ES0Stat-A-Dyne ESPESPESP2022-12-08
B770KN0Stat-A-Dyne KneeKneeKnee2022-12-08
B770PS0Stat-A-Dyne Pro/SupPRO/SUPPRO/SUP2022-12-08
B770SH0Stat-A-Dyne ShoulderShoulderShoulder2022-12-08
B770VEC0Vector 1Vector 1Vector 12022-12-08
B770WH0Stat-A-Dyne WHFOWHFOWHFO2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810079192724Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
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00810079192748Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192755Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192762Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192779Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192786Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192793Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
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00810079192946Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
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00810079192984Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079192991Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193004Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193011Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
00810079193028Thrive OrthopedicsThrive Orthopedics LLCIQI2026-05-27
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00636257213346MEDIMEDI MANUFACTURING, INC.IQI2026-04-24