FDA.report

Eleganz Fusion Screw System

Primary DI
00810190980682
Brand
Eleganz Fusion Screw System
Company
Dev4
Model
DI-2001
Device description
2.2mm Cannulated Drill, Short
Published
2025-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions

SubmissionSupplement
K250251000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250251000Eleganz Fusion Screw System (Fusion Screw System)Dev42025-06-13HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810190980682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810190980682008101909806828101909806820810190980682

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
832-257-0845jeff@dev-4.com

Regulatory Flags

DUNS number
119211016
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810190980705Eleganz Fusion Screw SystemDI-20042025-10-01
00860011634829SurePass CTR NS GuideCT-2000NS2025-05-20
00860011634836SurePass CTR NS BladeCT-2003NS2025-05-20

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