FDA.reportPublic FDA data

ELOS INSTRUMENTS

Primary DI
08056693001918
Brand
ELOS INSTRUMENTS
Company
INTRAUMA SPA
Model
SE225
Catalog number
SE225
Device description
Anti-Rotation Screw Ruler
Published
2023-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08056693001918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056693001918080566930019188056693001918

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
387588051
Device count
1
Lot or batch
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

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Primary DI, Brand, Company table
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