FDA.report

VADER Pedicle System Persuader Inline

Primary DI
07640164843124
Brand
VADER Pedicle System Persuader Inline
Company
icotec AG
Model
42-820
Catalog number
42-820
Device description
VADER Pedicle System Persuader Inline
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

Related Records

Contact Domains

Product Codes

CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640164843124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640164843124076401648431247640164843124

GMDN Terms

TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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07640172552605CMORE® System, In-line Handle, AO Coupling45-10045-1002025-11-24
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07640172552629CMORE® System, Solid Tap, Ø 4.0 mm 45-14045-1402025-11-24
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07640172552674CMORE® System, Template for Rods CT1, CT2, R12045-24045-2402025-11-24
07640172552681CMORE® System, Rod Cutter 45-25045-2502025-11-24
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07640172552759CMORE® System, Solid Tap, Ø 5.0 mm45-15045-1502025-11-24

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