FDA.report

VADER Pedicle System 6.0, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 45 mm

Primary DI
07640164844671
Brand
VADER Pedicle System 6.0, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 45 mm
Company
icotec AG
Model
16-6022-55545
Device description
VADER Pedicle System 6.0, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 45 mm
Published
2020-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PMLBone Cement, Posterior Screw Augmentation

Product Code Classifications

CodeDeviceSpecialtyClass
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640164844671PrimaryGS10

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods

Method

Contacts

PhoneEmail
+41717570000info@icotec.ch

Regulatory Flags

DUNS number
480789465
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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