FDA.reportPublic FDA data

ELOS

Primary DI
08056693000591
Brand
ELOS
Company
INTRAUMA SPA
Model
200.1801
Catalog number
200.1801
Device description
Trochanteric Nail
Published
2022-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201147000Elos® Intramedullary Nailing SystemIntrauma S.P.A2021-07-19HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056693000591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056693000591080566930005918056693000591

GMDN Terms#

Term, Definition table
TermDefinition
Femur nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length180Millimeter
Outer Diameter11Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
387588051
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056693001352ELOS200.0001200.00012022-09-12
08056693000126INTRAUMA SURGICAL INSTRUMENTS205S2052025-11-27
08056693001949WRISTAR MULTIAXKM1.9031KM1.90312025-11-27
08056693001956WRISTAR MULTIAXKM1.9032KM1.90322025-11-27
08056693001963WRISTAR MULTIAXKM1.9033KM1.90332025-11-27
08056693001970WRISTAR MULTIAXKM1.9034KM1.90342025-11-27
08056693001987WRISTAR MULTIAXKM1.9035KM1.90352025-11-27
08056693001994WRISTAR MULTIAXKM1.9036KM1.90362025-11-27
08056693002007WRISTAR MULTIAXKM1.9037KM1.90372025-11-27
08056693002014WRISTAR MULTIAXKM1.9038KM1.90382025-11-27
08056693002083MULTIAX SCREW120.2308120.23082025-11-27
08056693002090MULTIAX SCREW120.2310120.23102025-11-27
08056693002106MULTIAX SCREW120.2312120.23122025-11-27
08056693002113MULTIAX SCREW120.2314120.23142025-11-27
08056693002120MULTIAX SCREW120.2316120.23162025-11-27
08056693002137MULTIAX SCREW120.2318120.23182025-11-27
08056693002144MULTIAX SCREW120.2320120.23202025-11-27
08056693002151MULTIAX SCREW120.2322120.23222025-11-27
08056693002168MULTIAX SCREW120.2324120.23242025-11-27
08056693002175MULTIAX SCREW120.2326120.23262025-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869263NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869270NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869287NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869294NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869300NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869317NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869331NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869348NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869355NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869362NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869379NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869386NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869393NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869409NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869416NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869423NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869430NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06