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Ayers Rock Cervical interbody fusion system
FDA UDIClass II (US FDA UDI)
by Spineway SA
Identity
- Trade Name
- Ayers Rock Cervical interbody fusion system FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Container, Ayers Rock FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Container, Ayers Rock FDA UDI
Identifiers
- Catalog Number
- C1AR01 FDA UDI
- Primary DI / UDI-DI
- 03663422500007 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable 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
No
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
Ayers Rock Cervical interbody fusion system by Spineway SA — 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
- Spineway SA
Sources (1)
- FDA UDI 405e0596-b9c0-48c0-ad2f-90cd7b1aa24b 36 fields · synced May 30, 2026