Identity
- Trade Name
- ASTRA Spine System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Right 15mm Offset Hook, 8.0mm FDA UDI
- Model / Reference
- A5H-15RO80 FDA UDI
- Description
- Right 15mm Offset Hook, 8.0mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M824A5H15RO801 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDIMNH FDA UDIMNI FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3060 FDA UDI888.3070 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
ASTRA Spine System by Spinecraft Llc — 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
- Spinecraft Llc
Sources (1)
- FDA UDI f02d8695-542a-4283-a823-8f4f6edcdada 35 fields · synced Jun 1, 2026