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

FDA UDI

Class II (US FDA UDI)

by Icotec

Identity

Trade Name
VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm FDA UDI
Generic Name
Spinal intraoperative positioning pin, reusable FDA UDI
Device Name
VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm FDA UDI
Model / Reference
42-546 FDA UDI
Description
VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm FDA UDI

Identifiers

Catalog Number
42-546 FDA UDI
Primary DI / UDI-DI
07640172552100 FDA UDI
FDA Product Code
NKB FDA UDI
PML FDA UDI
GMDN Term
Spinal intraoperative positioning pin, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3027 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal intraoperative positioning pin, reusable

VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm by Icotec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal intraoperative positioning pin, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icotec

Sources (1)

  • FDA UDI 41fd5fe0-f5f0-4287-bd3c-08c323639cf5 35 fields · synced Jun 1, 2026