Identity
- Trade Name
- NEOSPACE FDA UDI
- Generic Name
- Polymeric spinal interbody fusion cage FDA UDI
- Device Name
- PEEK CERVICAL CAGE 6.5 mm FDA UDI
- Model / Reference
- 941.603 FDA UDI
- Description
- PEEK CERVICAL CAGE 6.5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07898624868068 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Polymeric spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
Neospace 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 6eebabf8-289d-4b33-9c56-e5bcd637edeb 35 fields · synced Jun 6, 2026