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Neuro Plating System

FDA UDI

Class II (US FDA UDI)

by OSTEONIC CO., Ltd.

Identity

Trade Name
Neuro Plating System FDA UDI
Generic Name
Cranioplasty plate, non-alterable FDA UDI
Device Name
Burr Hole Calvarium Plate, Long, 6Hole FDA UDI
Model / Reference
NBC304L06A FDA UDI
Description
Burr Hole Calvarium Plate, Long, 6Hole FDA UDI

Identifiers

Primary DI / UDI-DI
08809416061917 FDA UDI
510(k) Number
K141911 FDA UDI
K190811 FDA UDI
FDA Product Code
HBW FDA UDI
GXR FDA UDI
GWO FDA UDI
GMDN Term
Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5360 FDA UDI
882.5250 FDA UDI
882.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Category: Cranioplasty plate, non-alterable

Neuro Plating System by OSTEONIC CO., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, non-alterable.

Cleared under the same submission

K141911 also covers:

K190811 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OSTEONIC CO., Ltd.

Sources (1)

  • FDA UDI 8b1d3b6d-deda-4820-a5f2-b94413ec6993 34 fields · synced May 30, 2026