Home GUDID 07640164849614 icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm
Primary DI 07640164849614
Brand icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm
Company icotec AG
Model 16-6022-98555
Device description icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm
Published 2020-10-27
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System PML Bone Cement, Posterior Screw Augmentation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2 PML Bone Cement, Posterior Screw Augmentation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07640164849614 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07640164849614 07640164849614 7640164849614
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, sterile An 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.
Regulatory Flags# DUNS number 480789465 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07640172554227 VADER Pedicle System, Nut Screw, Ti 16-57-41000 16-57-41000 2026-04-30 07640172554234 VADER Pedicle System, Cross-Link, Ti, 30/34 mm 16-57-93034 16-57-93034 2026-04-30 07640172554241 VADER Pedicle System, Cross-Link, Ti, 33/42 mm 16-57-93442 16-57-93442 2026-04-30 07640172554258 VADER Pedicle System, Cross-Link, Ti, 40/53 mm 16-57-94053 16-57-94053 2026-04-30 07640172554265 VADER Pedicle System, Cross-Link, Ti, 50/70 mm 16-57-95070 16-57-95070 2026-04-30 07640172553824 CMORE® System, Torque Wrench, AO-Coupling 45-400H 45-400H 2025-11-24 07640172552872 icotec Systems, Torque-Limiting Adapter, 3.5 Nm 60-035 60-035 2025-03-05 07640172552889 VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm 42-596 42-596 2025-03-05 07640172552902 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm 42-546-1 42-546-1 2024-11-22 07640172552919 VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm 42-542-1 42-542-1 2024-11-22 07640172552087 VADER Pedicle System, K-wire, Ø 1.1 × 472 mm 42-541 42-541 2023-01-13 07640172552094 VADER Pedicle System, K-wire, Nitinol, Ø 1.1 × 472 mm 42-542 42-542 2023-01-13 07640172552100 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm 42-546 42-546 2023-01-13 07640164840871 VADER Pedicle System, K-wire, Ø 1.6 x 150 mm 42-545 42-545 2019-07-31 07640164846408 VADER Pedicle System, K-wire, threaded, Ø 1.6 x 472 mm 42-544 42-544 2019-07-31 07640172553916 KONG-TL VBR System, Guiding Sleeve for Locking Screwdriver 44-051 44-051 2026-01-29 07640172552544 CMORE® System, Awl 45-010 45-010 2025-11-24 07640172552551 CMORE® System, Pedicle Probe, Straight 45-020 45-020 2025-11-24 07640172552568 CMORE® System, Drill Guide Sleeve 45-030 45-030 2025-11-24 07640172552575 CMORE® System, Drill Guide Stop 45-030-1 45-030-1 2025-11-24
Other Devices Sharing Product Codes# 
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