Identity
- Trade Name
- CarboClear Lumbar Cage System FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- A surgical tool for use with the lumbar intervertebral body fusion device (cage). The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space. FDA UDI
- Model / Reference
- Implant Trial-10x23x14mm FDA UDI
- Description
- A surgical tool for use with the lumbar intervertebral body fusion device (cage). The Implant Trial is intended for use before insertion of the implant into the intervertebral space, to assist in selection of correct implant dimensions and to verify implant position within the disc space. FDA UDI
Identifiers
- Catalog Number
- CCLC02314 FDA UDI
- Primary DI / UDI-DI
- 07290110206871 FDA UDI
- 510(k) Number
- K193378 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
CarboClear Lumbar Cage System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193378 also covers:
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Lumbar Cage System — CARBOFIX ORTHOPEDICS LTD
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
- Carbofix Orthopedics Ltd
Sources (1)
- FDA UDI 78f48d94-7821-4995-a1d9-a8d1da529703 36 fields · synced May 30, 2026