FDA.reportPublic FDA data

Ponseti® Lite

Primary DI
00810060883419
Brand
Ponseti® Lite
Company
MD ORTHOPAEDICS, INC.
Model
LITE LONG BAR 10° BK/INSERTS
Catalog number
LITE LONG BAR 10° BK/INSERTS
Device description
PONSETI® LITE LONG BAR 10° BK/INSERTS
Published
2023-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ITNSplint, Denis Brown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITNSplint, Denis BrownPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810060883419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060883419008100608834198100608834190810060883419

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
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
00841517112622Sonosite STFUJIFILM SONOSITE, INC.ITN2026-05-01
00810060888438Mitchell Ponseti® Bracing SystemMD ORTHOPAEDICS, INC.ITN2026-03-12
00810060888407Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2024-01-17
00810060883365Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883372Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883389Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883396Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883402Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883426Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883433Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883440Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883457Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883464Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883471Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060880166Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880197Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880203Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880210Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880227Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880234Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880241Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880258Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880265Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880272Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880289Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880296Ponseti® Plus Abduction BarMD ORTHOPAEDICS, INC.ITN2023-10-12
00810060880005Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22
00810060880012Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22
00810060880029Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22
00810060880036Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22