FDA.reportPublic FDA data

Ponseti® Lite

Primary DI
00810060883396
Brand
Ponseti® Lite
Company
MD ORTHOPAEDICS, INC.
Model
LITE SHORT BAR 15° BK/INSERTS
Catalog number
LITE SHORT BAR 15° BK/INSERTS
Device description
PONSETI® LITE SHORT BAR 15° BK/INSERTS
Published
2023-11-21
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

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
00810060883396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810060883396008100608833968100608833960810060883396

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810060883402Ponseti® Lite MD ORTHOPAEDICS, INC.ITN2023-11-21
00810060883419Ponseti® 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
00810060880043Mitchell Ponseti® Move BarMD ORTHOPAEDICS, INC.ITN2023-03-22