Identity
- Trade Name
- SpineTune TL FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- CAN. POLY.REDUC. SCREW 6.5 L45 FDA UDI
- Model / Reference
- ST7354T-S FDA UDI
- Description
- CAN. POLY.REDUC. SCREW 6.5 L45 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03662663008198 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 45 Millimeter FDA UDIOuter Diameter — 6.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system, sterile
SpineTune TL by Ldr Spine USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system, sterile.
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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
- Ldr Spine USA
Sources (1)
- FDA UDI 5ed5b052-3133-49e2-9ca7-f589d9b49995 35 fields · synced Jun 6, 2026