FDA.reportPublic FDA data

VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm

Primary DI
07640172552889
Brand
VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm
Company
icotec AG
Model
42-596
Catalog number
42-596
Device description
VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm
Published
2025-03-05
Public version status
Update
Distribution status
Not 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
07640172552889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640172552889076401725528897640172552889

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
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
07640172552582CMORE® System, Drill Bit, Ø 2.3 mm45-04045-0402025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12