FDA.reportPublic FDA data

VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm

Primary DI
07640164846408
Brand
VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm
Company
icotec AG
Model
42-544
Catalog number
42-544
Device description
VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm
Published
2019-07-31
Public version status
Update
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640164846408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640164846408076401648464087640164846408

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
07640172552582CMORE® System, Drill Bit, Ø 2.3 mm45-04045-0402025-11-24
07640172552599CMORE® System, Feeler45-07045-0702025-11-24
07640172552605CMORE® System, In-line Handle, AO Coupling45-10045-1002025-11-24
07640172552612CMORE® System, Palm Handle, AO Coupling45-11045-1102025-11-24
07640172552629CMORE® System, Solid Tap, Ø 4.0 mm 45-14045-1402025-11-24
07640172552636CMORE® System, Solid Tap, Ø 4.5 mm45-14545-1452025-11-24
07640172552643CMORE® System, Screwdriver Shaft, T1545-21045-2102025-11-24
07640172552650CMORE® System, Tulip Aligner 45-22045-2202025-11-24
07640172552674CMORE® System, Template for Rods CT1, CT2, R12045-24045-2402025-11-24
07640172552681CMORE® System, Rod Cutter 45-25045-2502025-11-24
07640172552698CMORE® System, French Rod Bender 45-26045-2602025-11-24
07640172552704CMORE® System, Rod Gripper45-28045-2802025-11-24
07640172552711CMORE® System, Compressor45-34045-3402025-11-24
07640172552728CMORE® System, Distractor45-36045-3602025-11-24
07640172552759CMORE® System, Solid Tap, Ø 5.0 mm45-15045-1502025-11-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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