FDA.reportPublic FDA data

Surjex

Primary DI
G383NECKELEVATOR87
Brand
Surjex
Company
SURJEX
Model
WM8535437
Catalog number
WM8535437
Device description
"Femoral Neck Elevator Length 13"" Handle Length 9"" Blade Wide 25MM"
Published
2024-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G383NECKELEVATOR87PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645518882
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G383S1061WM1413S3SURJEXWM1413S3WM1413S32026-05-31
G383S1061WM3240913SURJEXWM3240913WM32409132026-05-31
G383S1061WM3245624S7SURJEXWM3245624WM32456242026-05-31
G383S1061WM8535433SURJEXWM8535433WM85354332026-05-31
G383S1061WM8535437SURJEXWM8535437WM85354372026-05-31
G383WM3241113SURJEXWM3241113WM32411132026-05-31
G3831056WM853543SURJEXWM85354372026-01-31
G3831056WM8535433SURJEXWM85354332026-01-31
G3831056WM8769923SURJEXWM8769923WM87699232026-01-31
G3831056WM8769924SURJEXWM8769924WM87699242026-01-31
G3831056WM8769925SURJEXWM8769925WM87699252026-01-31
G383S105823WM9542161SURJEXWM9542161WM95421612026-01-31
G383WM7778700SURJEXWM7778700WM77787002026-01-31
G383WM7778701SURJEXWM7778701WM77787012026-01-31
G383WM7778702SURJEXWM7778702WM77787022026-01-31
G383WM7778703SURJEXWM7778703WM77787032026-01-31
G383WM8769920SURJEXWM87699202026-01-31
G383WM8769921SURJEXWM8769921WM87699212026-01-31
G383WM8769922SURJEXWM8769922WM87699222026-01-31
G3831053WM0315CWB5SURJEXWM0315-CWM0315-C2024-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400583MillenniumAvalign Technologies, Inc.GEG2026-07-19
18257200087433ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCGEG2026-07-17
B382SD6216030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216060Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD6216080Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907037100T0Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD9070451100Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907075030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD92268003T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268030T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268031T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268032T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268033T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268034T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268035T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268036T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268037T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268038T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268039T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268040T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268041T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268042T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268043T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268044T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268045T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268046T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268047T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268048T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD9147091800Surgical DirectSurgical Direct, Inc.GEG2026-07-09
00850083275822Intrace USAPILOTIS TECH LLCGEG2026-07-03