Identity
- Trade Name
- TirboLOX-L Lumbar IBFD FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- TRIAL Lordotic 6° CAGE 32mm x 8.5mm x 12mm FDA UDI
- Model / Reference
- 19368-3212 FDA UDI
- Description
- TRIAL Lordotic 6° CAGE 32mm x 8.5mm x 12mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7391936832120 FDA UDI
- 510(k) Number
- K180990 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
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
Category: Spinal implant trial
TirboLOX-L Lumbar IBFD by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal implant trial.
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- IdentiTi — ALPHATEC SPINE, INC. · Class II
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- ROI-A — Ldr Spine USA · Class II
Cleared under the same submission
K180990 also covers:
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
- TirboLOX-L Lumbar IBFD — Captiva Spine
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
- Captiva Spine
Sources (1)
- FDA UDI 8a3b53d0-8481-479d-a678-3c84ca7ac67a 35 fields · synced Jun 8, 2026