Identity
- Trade Name
- SpineTune TL FDA UDI
- Generic Name
- Orthopaedic bone screw starter/notcher FDA UDI
- Model / Reference
- ST9026R FDA UDI
Identifiers
- Catalog Number
- ST9026R FDA UDI
- Primary DI / UDI-DI
- 03662663045117 FDA UDI
- FDA Product Code
- HXB FDA UDI
- GMDN Term
- Orthopaedic bone screw starter/notcher FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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
Category: Orthopaedic bone screw starter/notcher
SpineTune TL by Ldr Spine USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw starter/notcher.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ldr Spine USA
Sources (1)
- FDA UDI 19334ded-b6c6-4b6a-8e31-1a3e2eb9943b 34 fields · synced Jun 8, 2026