Identity
- Trade Name
- EquiLOX Lumbar Expandable Cage FDA UDI
- Generic Name
- Spinal fusion sphere FDA UDI
- Device Name
- Expandable Lumbar Cage 28mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA) FDA UDI
- Model / Reference
- CSF0301-B0028AC5FS FDA UDI
- Description
- Expandable Lumbar Cage 28mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA) FDA UDI
Identifiers
- Catalog Number
- 00850065741178 FDA UDI
- Primary DI / UDI-DI
- 00850065741178 FDA UDI
- 510(k) Number
- K232069 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Spinal fusion sphere 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Spinal fusion sphere
EquiLOX Lumbar Expandable Cage by Captiva Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fusion sphere.
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- TirboLOX-C Cervical IBFD — Captiva Spine · Class II
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
- TirboLOX-L Lumbar IBFD — Captiva Spine · Class II
Cleared under the same submission
K232069 also covers:
- EquiLOX Expandable Lumbar Cage, Anatomic — Captiva Spine
- EquiLOX Expandable Lumbar Cage, Anatomic — Captiva Spine
- EquiLOX Expandable Lumbar Cage, Anatomic — Captiva Spine
- EquiLOX Expandable Lumbar Cage, Anatomic — Captiva Spine
- EquiLOX Expandable Lumbar Cage, Anatomic — Captiva Spine
- EquiLOX Expandable Lumbar Cage, Anatomic — Captiva Spine
- EquiLOX Lumbar Expandable Cage — Captiva Spine
- EquiLOX Lumbar Expandable Cage — Captiva Spine
- EquiLOX Lumbar Expandable Cage — Captiva Spine
- EquiLOX Lumbar Expandable Cage — Captiva Spine
- EquiLOX Lumbar Expandable Cage — Captiva Spine
- EquiLOX Lumbar Expandable Cage — 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 9d306d84-b99e-44f9-8fe5-d90017d6b91b 36 fields · synced May 31, 2026