FDA.reportPublic FDA data

Elite Orthopaedics

Primary DI
00816591011727
Brand
Elite Orthopaedics
Company
Elite Orthopaedics, Inc.
Model
T58122
Catalog number
T58122
Device description
Premiere Posterior Night Splint, Small
Published
2023-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ITWJoint, Ankle, External Brace

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816591011727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816591011727008165910117278165910117270816591011727

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
803168228
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816591010690Elite Orthopaedics30061-R30061-R2023-08-17
00816591010706Elite Orthopaedics30061-L30061-L2023-08-17
00816591010713Elite Orthopaedics30062-R30062-R2023-08-17
00816591010720Elite Orthopaedics30062-L30062-L2023-08-17
00816591010737Elite Orthopaedics30063-R30063-R2023-08-17
00816591010744Elite Orthopaedics30063-L30063-L2023-08-17
00816591010751Elite Orthopaedics30064-R30064-R2023-08-17
00816591010768Elite Orthopaedics30064-L30064-L2023-08-17
00816591010775Elite Orthopaedics30065-R30065-R2023-08-17
00816591010782Elite Orthopaedics30065-L30065-L2023-08-17
00816591010799Elite Orthopaedics31061-R31061-R2023-08-18
00816591010805Elite Orthopaedics31062-R31062-R2023-08-18
00816591010812Elite Orthopaedics31063-R31063-R2023-08-18
00816591010829Elite Orthopaedics31064-R31064-R2023-08-18
00816591010836Elite Orthopaedics31065-R31065-R2023-08-18
00816591010843Elite Orthopaedics31061-L31061-L2023-08-18
00816591010850Elite Orthopaedics31062-L31062-L2023-08-18
00816591010867Elite Orthopaedics31063-L31063-L2023-08-18
00816591010874Elite Orthopaedics31064-L31064-L2023-08-18
00816591010881Elite Orthopaedics31065-L31065-L2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178885398CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885404CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885411CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885428CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885435CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885442CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885459CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885466CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885473CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885480CoreTechVIVE HEALTH LLCITW2026-05-05
00810178886135ViveVIVE HEALTH LLCITW2026-05-05
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113683898FlexSafe Ankle Recovery Orthosis, LargeManamed, Inc.ITW2025-10-31
00810113683904FlexSafe Ankle Recovery Orthosis, MediumManamed, Inc.ITW2025-10-31
00810113683911FlexSafe Ankle Recovery Orthosis, SmallManamed, Inc.ITW2025-10-31
00810113683928FlexSafe Ankle Recovery Orthosis, Extra LargeManamed, Inc.ITW2025-10-31
00810113683935FlexSafe Ankle Recovery Orthosis, Extra Small Manamed, Inc.ITW2025-10-31
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579825ViveVIVE HEALTH LLCITW2025-05-20
00810113579832ViveVIVE HEALTH LLCITW2025-05-20
00810113579849ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579443CoreTechVIVE HEALTH LLCITW2024-10-24