Identity
- Trade Name
- CarboClear Lumbar Cage System FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- A lumbar intervertebral body fusion device FDA UDI
- Model / Reference
- Cubic Cage FDA UDI
- Description
- A lumbar intervertebral body fusion device FDA UDI
Identifiers
- Catalog Number
- CCLC2710 FDA UDI
- Primary DI / UDI-DI
- 07290110206543 FDA UDI
- 510(k) Number
- K193378 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 10 Millimeter FDA UDILength — 27 Millimeter FDA UDIHeight — 10 Millimeter FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
CarboClear Lumbar Cage System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-polymer composite spinal interbody fusion cage.
- Battalion Universal Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
- Irix-A Lumbar Integrated Fusion System — Xtant Medical Holdings, Inc. · Class II
- Tyber Medical — Tyber Medical · Class II
- Reef TA — SeaSpine Orthopedics Corporation · Class II
- ROI-C — Ldr Spine USA · Class II
- LUCENT XP ARC — SPINAL ELEMENTS, INC. · Class II
- Shoreline ACS — SeaSpine Orthopedics Corporation · Class II
- MIDLINE II-Ti — Centinel Spine, LLC · Class II
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 d7ceefe5-cc1e-487c-9a4f-11fa40e3fd7f 37 fields · synced May 30, 2026