FDA.reportPublic FDA data

Lunaris® Essential

Primary DI
05404036502821
Brand
Lunaris® Essential
Company
Axiles Bionics
Model
Lunaris Essential
Catalog number
LESC2SXXZ
Device description
Articulated prosthetic ankle-foot component with spring category C2. The device is intended for the replacement of the ankle and foot function as a component of a prosthesis that compensates for an absent or deficient lower limb.
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISHComponent, External, Limb, Ankle/Foot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISHComponent, External, Limb, Ankle/FootPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05404036502821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404036502821054040365028215404036502821

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical-resistance external ankle-foot prosthesisA mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle, wherein the principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media). The device may have various designs and functional features (e.g., SACH, SAFE, partial-foot, energy-storing carbon fibre spring blade type, adjustable heel height, split/sandal toe) for support during a variety of activities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length24Centimeter
Length25Centimeter
Length26Centimeter
Length27Centimeter
Length28Centimeter
Length29Centimeter
Length30Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999info@axilesbionics.com

Regulatory Flags#

DUNS number
371723288
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404036502838Lunaris® EssentialLunaris EssentialLESC3SXXZ2025-05-12
05404036502845Lunaris® EssentialLunaris EssentialLESC4SXXZ2025-05-12
05404036502852Lunaris® EssentialLunaris EssentialLESC5SXXZ2025-05-12
05404036502869Lunaris® EssentialLunaris EssentialLESC6SXXZ2025-05-12
05404036502876Lunaris® EssentialLunaris EssentialLESC7SXXZ2025-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195411212033ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212040ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212057ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212064ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212071ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212088ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212095ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212101ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212118ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212125ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212132ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212149ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212156ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212163ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212170ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212187ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212194ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212200ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212217ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212224ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212231ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212248ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212255ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212262ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212279ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212286ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212293ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212309ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411212316ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19
00195411419470ScoutCOLLEGE PARK INDUSTRIES, INC.ISH2024-06-19