FDA.report

MD Orthopaedics

Primary DI
00810060884201
Brand
MD Orthopaedics
Company
MD ORTHOPAEDICS, INC.
Model
AFO-0000-R-COLORS
Device description
Ankle foot orthosis, prefabricated (single), to be attached to abduction brace, L1930 AFO SIZE 0000 RIGHT CUSTOM COLOR
Published
2020-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KNPOrthosis, Corrective Shoe

Product Code Classifications

CodeDeviceSpecialtyClass
KNPOrthosis, Corrective ShoePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810060884201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060884201008100608842018100608842010810060884201

GMDN Terms

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

Regulatory Flags

DUNS number
146220269
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
00810060888438Mitchell Ponseti® Bracing SystemHDWEKIT2026-03-12
00810060888582Mitchell Ponseti® Bracing SystemUNIVERSAL MOUNT KIT2025-12-15
00810060888599Mitchell Ponseti® Bracing SystemPS-SM2025-12-15
00810060888605Mitchell Ponseti® Bracing SystemPS-LG2025-12-15
00810060887394Rhino Cruiser Hip Abduction Brace - Large271042024-10-29
00810060887400Rhino Cruiser Hip Abduction Brace - Extra Large271052024-10-29
00810060888414Rhino 2737122737122024-05-21
00810060888407Ponseti® Plus Abduction BarGEARED QUICK CLIP KIT 0°GEARED QUICK CLIP KIT 0°2024-01-17
00810060888100Rhino Leg Strap Pink - Preemie273502024-01-02
00810060888117Rhino Leg Strap Pink - Extra Small273512024-01-02
00810060888124Rhino Leg Strap Pink - Small273522024-01-02
00810060888131Rhino Leg Strap Pink - Medium273532024-01-02
00810060888148Rhino Leg Strap Pink - Large273542024-01-02
00810060888155Rhino Chest Strap Pink - Preemie2735502024-01-02
00810060888162Rhino Chest Strap Pink - Extra Small2735512024-01-02
00810060888179Rhino Chest Strap Pink - Small2735522024-01-02
00810060888186Rhino Chest Strap Pink - Medium2735532024-01-02
00810060888193Rhino Chest Strap Pink - Large2735542024-01-02
00810060888209Rhino Leg Strap Blue - Preemie273602024-01-02
00810060888216Rhino Leg Strap Blue - Extra Small273612024-01-02

Other Devices Sharing Product Codes

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