FDA.reportPublic FDA data

Eleganz Fusion Screw System

Primary DI
00810190980835
Brand
Eleganz Fusion Screw System
Company
Dev4
Model
DI-2522
Device description
Ratcheting Driver Handle
Published
2025-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00810190980835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810190980835008101909808358101909808350810190980835

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00193082164828ORIO-3D Cage SystemSPINECRAFT, LLCLXH2026-07-30
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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
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