Identity
- Trade Name
- Neuro Plating System FDA UDI
- Generic Name
- Cranioplasty plate screw FDA UDI
- Device Name
- 1x Magazine + 1x Cover + 6x Screws 5mm FDA UDI
- Model / Reference
- TSN-014 FDA UDI
- Description
- 1x Magazine + 1x Cover + 6x Screws 5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809595972974 FDA UDI
- FDA Product Code
- HBW FDA UDIGXR FDA UDIGWO FDA UDI
- GMDN Term
- Cranioplasty plate screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5360 FDA UDI882.5250 FDA UDI882.5320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Cranioplasty plate screw
Neuro Plating System by OSTEONIC CO., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cranioplasty plate screw.
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Cleared under the same submission
K183352 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.
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 |
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Manufacturer
- Manufacturer
- OSTEONIC CO., Ltd.
Sources (1)
- FDA UDI 80e2dbeb-b983-4e4c-8848-58e721d1b5cd 34 fields · synced Jun 8, 2026