Identity
- Trade Name
- ASTRA Spine System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- ASTRA Side-by-Side Connector, Open, Side-Loading, fitting 5.5, 6mm, and 6+H1808.35mm - 12mm Offset FDA UDI
- Model / Reference
- A5D-OS2 FDA UDI
- Description
- ASTRA Side-by-Side Connector, Open, Side-Loading, fitting 5.5, 6mm, and 6+H1808.35mm - 12mm Offset FDA UDI
Identifiers
- Primary DI / UDI-DI
- M824A5DOS21 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWQ FDA UDINKB FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 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 ef6399a7-4252-415c-a83f-23e401a6db53 35 fields · synced May 31, 2026