FDA.reportPublic FDA data

iLESSYS® Interlaminar Endoscopic Surgical System

Primary DI
04250337122432
Brand
iLESSYS® Interlaminar Endoscopic Surgical System
Company
Joimax GmbH
Model
ILESSYSDL7
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337122432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337122432042503371224324250337122432

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49721255140info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337100942Sealing CapSCLL15202026-10-29
04250337112860Closing Cap for joimax® endoscopesTCC2008052026-10-29
04250337118831joimax® Vitegra® Foot SwitchJVFS00012026-10-29
04250337120308Biportal Laminoscope, okularBS4015175O-4K2026-10-29
04250337120605Biportal Laminoscope, okularBS4000175O-4K2026-10-29
04250337120643Biportal Laminoscope, okularBS4030175O-4K2026-10-29
04250337120971Camsource® Duo Control UnitCSD4K012026-10-29
04250337121053Endoscope Adapter for iLESSYS® Delta LaminoscopeRFEAID10A2026-10-29
04250337121060Coupling nut for endoscope adapterRFEACS2026-10-29
04250337121077Adapter holderRFADH2026-10-29
04250337121084HofHolderEHFS63422026-10-29
04250337121107HofHolderEHFS6342-4K2026-10-29
04250337121114HofHolderEHFS7342-4K2026-10-29
04250337121121HofHolderEHFS73422026-10-29
04250337121138HofHolderEHLS1006-4K2026-10-29
04250337121145HofHolderEHLS10062026-10-29
04250337121152HofHolderEHLS7342-4K2026-10-29
04250337121169HofHolderEHLS73422026-10-29
04250337121183Locking screw for endoscope adapterRFEALS2026-10-29
04250337121626joimax® Intracs® EM Patient Tracker 3DJINTPT3D2026-10-29

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Primary DI, Brand, Company table
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00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
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10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
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M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28