FDA.reportPublic FDA data

MD Orthopaedics

Primary DI
00810060883723
Brand
MD Orthopaedics
Company
MD ORTHOPAEDICS, INC.
Model
AFO-0-LB
Device description
AFO SIZE 0 LEFT BLUE
Published
2020-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KNPOrthosis, Corrective Shoe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060883723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060883723008100608837238100608837230810060883723

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisAn externally-applied 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; 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. It is made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
146220269
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
00810060888674Mitchell Ponseti® Bracing SystemAFO-0000-PRCDAFO-0000-PRCD2026-04-30
00810060888681Mitchell Ponseti® Bracing SystemAFO-000-PRCDAFO-000-PRCD2026-04-30
00810060888698Mitchell Ponseti® Bracing SystemAFO-00-PRCDAFO-00-PRCD2026-04-30
00810060888704Mitchell Ponseti® Bracing SystemAFO-0-PRCDAFO-0-PRCD2026-04-30
00810060888711Mitchell Ponseti® Bracing SystemAFO-1-PRCDAFO-1-PRCD2026-04-30
00810060888728Mitchell Ponseti® Bracing SystemAFO-2-PRCDAFO-2-PRCD2026-04-30
00810060888735Mitchell Ponseti® Bracing SystemAFO-3-PRCDAFO-3-PRCD2026-04-30
00810060888742Mitchell Ponseti® Bracing SystemAFO-4-PRCDAFO-4-PRCD2026-04-30
00810060888759Mitchell Ponseti® Bracing SystemAFO-5-PRCDAFO-5-PRCD2026-04-30
00810060888766Mitchell Ponseti® Bracing SystemAFO-6-PRCDAFO-6-PRCD2026-04-30
00810060888773Mitchell Ponseti® Bracing SystemAFO-7-PRCDAFO-7-PRCD2026-04-30
00810060888780Mitchell Ponseti® Bracing SystemAFO-8-PRCDAFO-8-PRCD2026-04-30
00810060888797Mitchell Ponseti® Bracing SystemAFO-9-PRCDAFO-9-PRCD2026-04-30
00810060888803Mitchell Ponseti® Bracing SystemAFO-10-PRCDAFO-10-PRCD2026-04-30
00810060888810Mitchell Ponseti® Bracing SystemAFO-11-PRCDAFO-11-PRCD2026-04-30
00810060888827Mitchell Ponseti® Bracing SystemAFO-12-PRCDAFO-12-PRCD2026-04-30
00810060888834Mitchell Ponseti® Bracing SystemAFO-2-LCD -TSAFO-2-LCD -TS2026-04-30
00810060888841Mitchell Ponseti® Bracing SystemAFO-2-RCD -TSAFO-2-RCD -TS2026-04-30
00810060888858Mitchell Ponseti® Bracing SystemAFO-3-LCD -TSAFO-3-LCD -TS2026-04-30
00810060888865Mitchell Ponseti® Bracing SystemAFO-3-RCD -TSAFO-3-RCD -TS2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178886319CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886326CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886333CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886340CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886357CoreTechVIVE HEALTH LLCKNP2026-02-03
00810178886364CoreTechVIVE HEALTH LLCKNP2026-02-03
00810060888582Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888599Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
00810060888605Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.KNP2025-12-15
06978785665087InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
06978785665094InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-12-08
00810195430755CadenseCadense, Inc.KNP2025-08-18
06978785665025InhwRiorShenzhen Yuechuan trade Co., Ltd.KNP2025-07-09
10810178880161ViveVIVE HEALTH LLCKNP2025-07-08
10810178880178ViveVIVE HEALTH LLCKNP2025-07-08
10810178880185ViveVIVE HEALTH LLCKNP2025-07-08
10810178880192ViveVIVE HEALTH LLCKNP2025-07-08
10810178880208ViveVIVE HEALTH LLCKNP2025-07-08
00810195430557CadenseCadense, Inc.KNP2025-07-08
00810195430564CadenseCadense, Inc.KNP2025-07-08
00810195430571CadenseCadense, Inc.KNP2025-07-08
00810195430588CadenseCadense, Inc.KNP2025-07-08
00609271120167POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120174POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120181POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120198POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120204POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120211POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120228POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15
00609271120235POGO™ PulsusDARCO INTERNATIONAL, INC.KNP2025-04-15