Identity
- Trade Name
- CarboClear Lumbar Cage System FDA UDI
- Generic Name
- Bone graft funnel FDA UDI
- Device Name
- A surgical tool used for the introduction of bone graft into the intervertebral space FDA UDI
- Model / Reference
- Bone Funnel FDA UDI
- Description
- A surgical tool used for the introduction of bone graft into the intervertebral space FDA UDI
Identifiers
- Catalog Number
- CCLC9050 FDA UDI
- Primary DI / UDI-DI
- 07290110206611 FDA UDI
- 510(k) Number
- K193378 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Bone graft funnel 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: Bone graft funnel
CarboClear Lumbar Cage System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone graft funnel.
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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 7ed5e275-5d30-4d64-8163-e4e19bf90768 36 fields · synced May 30, 2026