FDA.reportPublic FDA data

VADER Pedicle System, Outer Alignment Sleeve

Primary DI
07640164840741
Brand
VADER Pedicle System, Outer Alignment Sleeve
Company
icotec AG
Model
42-425-1
Device description
VADER Pedicle System, Outer Alignment Sleeve
Published
2020-10-27
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
NKBThoracolumbosacral Pedicle Screw System
PMLBone Cement, Posterior Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640164840741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640164840741076401648407417640164840741

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

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
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13