Identity
- Trade Name
- ASTRA Spine System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- ASTRA 5.5mm CoCr MIS Fixed Lordosed Rod, 130mm FDA UDI
- Model / Reference
- A5R-55FL-130K FDA UDI
- Description
- ASTRA 5.5mm CoCr MIS Fixed Lordosed Rod, 130mm FDA UDI
Identifiers
- Catalog Number
- A5R-55FL-130K FDA UDI
- Primary DI / UDI-DI
- M824A5R55FL130K1 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDINKB FDA UDIKWQ FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod 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 ea190dca-eebd-45c8-a744-5caf3359a7f6 36 fields · synced May 31, 2026