Identity
- Trade Name
- Neuro Plating System FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- 3 x straight 2 hole plates 15.4mm + 6 self drilling screws Ø1.5 x 4.0mm FDA UDI
- Model / Reference
- TCN-011 FDA UDI
- Description
- 3 x straight 2 hole plates 15.4mm + 6 self drilling screws Ø1.5 x 4.0mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809595972837 FDA UDI
- 510(k) Number
- K190811 FDA UDI
- FDA Product Code
- GWO FDA UDIGXR FDA UDIHBW FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5320 FDA UDI882.5250 FDA UDI882.5360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
Neuro Plating System by OSTEONIC CO., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
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- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
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- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
Cleared under the same submission
K190811 also covers:
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
- Neuro Plating System — OSTEONIC CO., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OSTEONIC CO., Ltd.
Sources (1)
- FDA UDI a53c2925-cfe1-4914-9ca4-209f5e4f5527 34 fields · synced Jun 8, 2026