FDA.reportPublic FDA data

VADER Pedicle System, Navigation Adapter

Primary DI
07640172552391
Brand
VADER Pedicle System, Navigation Adapter
Company
icotec AG
Model
42-680N
Catalog number
42-680N
Device description
VADER Pedicle System, Navigation Adapter
Published
2023-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640172552391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172552391076401725523917640172552391

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41717570000info@icotec.ch

Regulatory Flags#

DUNS number
480789465
Device count
1
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
07640172554227VADER Pedicle System, Nut Screw, Ti16-57-4100016-57-410002026-04-30
07640172554234VADER Pedicle System, Cross-Link, Ti, 30/34 mm16-57-9303416-57-930342026-04-30
07640172554241VADER Pedicle System, Cross-Link, Ti, 33/42 mm16-57-9344216-57-934422026-04-30
07640172554258VADER Pedicle System, Cross-Link, Ti, 40/53 mm16-57-9405316-57-940532026-04-30
07640172554265VADER Pedicle System, Cross-Link, Ti, 50/70 mm16-57-9507016-57-950702026-04-30
07640172553824CMORE® System, Torque Wrench, AO-Coupling45-400H45-400H2025-11-24
07640172552872icotec Systems, Torque-Limiting Adapter, 3.5 Nm60-03560-0352025-03-05
07640172552889VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm42-59642-5962025-03-05
07640172552902VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm42-546-142-546-12024-11-22
07640172552919VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm42-542-142-542-12024-11-22
07640172552087VADER Pedicle System, K-wire, Ø 1.1 × 472 mm42-54142-5412023-01-13
07640172552094VADER Pedicle System, K-wire, Nitinol, Ø 1.1 × 472 mm42-54242-5422023-01-13
07640172552100VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm42-54642-5462023-01-13
07640164840871VADER Pedicle System, K-wire, Ø 1.6 x 150 mm42-54542-5452019-07-31
07640164846408VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm42-54442-5442019-07-31
07640172553916KONG-TL VBR System, Guiding Sleeve for Locking Screwdriver44-05144-0512026-01-29
07640172552544CMORE® System, Awl45-01045-0102025-11-24
07640172552551CMORE® System, Pedicle Probe, Straight45-02045-0202025-11-24
07640172552568CMORE® System, Drill Guide Sleeve45-03045-0302025-11-24
07640172552575CMORE® System, Drill Guide Stop45-030-145-030-12025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882433ION-C Navigation LocatorSurgentec, LLCOLO2026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSurgentec, LLCOLO2026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSurgentec, LLCOLO2026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSurgentec, LLCOLO2026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSurgentec, LLCOLO2026-07-06
00810131882556TiLink-L Navigation Drill GuideSurgentec, LLCOLO2026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSurgentec, LLCOLO2026-07-06
00810131882617TiLink-L Navigation Impact CapSurgentec, LLCOLO2026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSurgentec, LLCOLO2026-07-06
00810131883669Ion Navigation Inserter AOSurgentec, LLCOLO2026-07-06
00810131884871ION-C Navigation Reusable TraySurgentec, LLCOLO2026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySurgentec, LLCOLO2026-07-06
10705034647845TRIALTISMedos International SàrlOLO2026-07-04
10705034647852TRIALTISMedos International SàrlOLO2026-07-04
10705034647883TRIALTISMedos International SàrlOLO2026-07-04
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08