Screw Torx Slot

FDA UDI

Class II (US FDA UDI)

by Neurovention LLC

Identity

Trade Name: Screw Torx Slot FDA UDI
Generic Name: Cranioplasty plate screw FDA UDI
Device Name: Screw Torx Slot 2mm x 6 mm FDA UDI
Model / Reference: 241-01 FDA UDI
Description: Screw Torx Slot 2mm x 6 mm FDA UDI

Identifiers

Primary DI / UDI-DI: G284241019 FDA UDI
510(k) Number: K192162 FDA UDI
FDA Product Code: HBW FDA UDI
GMDN Term: Cranioplasty plate screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cranioplasty plate screw

Screw Torx Slot by Neurovention LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate screw.

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Neuro Plating System — OSTEONIC CO., Ltd. · Class II
STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC · Class II
Innovasis® Cranial System — Innovasis, Inc. · Class II
Neuro Plating System — OSTEONIC CO., Ltd. · Class II

Cleared under the same submission

K192162 also covers:

Drill Bit — Neurovention LLC
KTC Burr Hole Cover — Neurovention LLC
KTC Burr Hole Cover — Neurovention LLC
NuCrani Large Plate — Neurovention LLC
NuCrani Small Plate — Neurovention LLC
Rescue Screw Torx Slot — Neurovention LLC
Screw T6 Torx — Neurovention LLC
Screw Torx Slot — Neurovention LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Neurovention LLC

Sources (1)

FDA UDI ceb704bc-6b26-42dc-af48-b94de66a1da0 34 fields · synced May 31, 2026