Identity
- Trade Name
- NEOPLATE FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Cervical Bicortical Screw SH D3.5x14 mm FDA UDI
- Model / Reference
- 942.701 FDA UDI
- Description
- Cervical Bicortical Screw SH D3.5x14 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898624867924 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Neoplate by Neoortho Produtos Ortopédicos S/A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Neoortho Produtos Ortopédicos S/A.
Sources (1)
- FDA UDI a4a67f63-f446-4863-92c3-4faa700a1c35 35 fields · synced Jun 8, 2026