FDA.reportPublic FDA data

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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250251000Eleganz Fusion Screw System (Fusion Screw System)Dev42025-06-13HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810190980682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810190980682008101909806828101909806820810190980682

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
832-257-0845jeff@dev-4.com

Regulatory Flags#

DUNS number
119211016
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810190981023Eleganz IM Threaded NailMC-25112026-04-23
00810190981030Eleganz IM Threaded NailMC-25132026-04-23
00810190981047Eleganz IM Threaded NailMC-25152026-04-23
00810190981054Eleganz IM Threaded NailMC-25172026-04-23
00810190981061Eleganz IM Threaded NailMC-25192026-04-23
00810190981078Eleganz IM Threaded NailMC-25212026-04-23
00810190981085Eleganz IM Threaded NailMC-25232026-04-23
00810190981092Eleganz IM Threaded NailMC-25252026-04-23
00810190981108Eleganz IM Threaded NailMC-25302026-04-23
00810190981115Eleganz IM Threaded NailMC-25352026-04-23
00810190981122Eleganz IM Threaded NailMC-25402026-04-23
00810190981139Eleganz IM Threaded NailMC-25452026-04-23
00810190981146Eleganz IM Threaded NailMC-25502026-04-23
00810190981153Eleganz IM Threaded NailMC-25552026-04-23
00810190981160Eleganz IM Threaded NailMC-25602026-04-23
00810190981177Eleganz IM Threaded NailMC-25652026-04-23
00810190981184Eleganz IM Threaded NailMC-25702026-04-23
00810190981191Eleganz IM Threaded NailMC-25752026-04-23
00810190981207Eleganz IM Threaded NailMC-35252026-04-23
00810190981214Eleganz IM Threaded NailMC-35302026-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376544519InvictusALPHATEC SPINE, INC.LXH2026-07-30
00193082164828ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167416ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167430ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167447ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167454ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167461ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167478ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
00193082167492ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00193082167508ANTERIS Thoracolumbar Plate SystemSPINECRAFT, LLCLXH2026-07-30
00199150081905Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-30
00810166521703X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523004X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00810166523011X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
00850041805863X-PACEXPANDING INNOVATIONS, INC.LXH2026-07-30
04251631412526BEE PLIF CageNGMedical GmbHLXH2026-07-30
07899258632346Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258634647Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653242Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653259Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653266Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653280Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
07899258653297Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-07-30
09421028110853Tensioner, AP SizerENZTEC LIMITEDLXH2026-07-30
09421028110877Tensioner, BalancerENZTEC LIMITEDLXH2026-07-30
09421028110884Tensioner, DistractorENZTEC LIMITEDLXH2026-07-30
00198506093487ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093500ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093524ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29
00198506093548ELMED INCORPORATEDELMED INCORPORATEDLXH2026-07-29