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SCARLET® AL-T Intervertebral body fusion device
FDA UDIClass II (US FDA UDI)
by Spineart
Identity
- Trade Name
- SCARLET® AL-T Intervertebral body fusion device FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Bone Screw FDA UDI
- Model / Reference
- SJT-LS 55 45-S FDA UDI
- Description
- Bone Screw FDA UDI
Identifiers
- Catalog Number
- SJT-LS 55 45-S FDA UDI
- Primary DI / UDI-DI
- 07640178986923 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
SCARLET® AL-T Intervertebral body fusion device by Spineart — 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
- Spineart
Sources (1)
- FDA UDI c3984f8b-41af-49f6-8972-77eb99d098ee 36 fields · synced Jun 1, 2026