Identity
- Trade Name
- CarboClear Cervical Plate System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Anterior fixation cervical plate FDA UDI
- Model / Reference
- Cervical Plate 1 level 24 mm FDA UDI
- Description
- Anterior fixation cervical plate FDA UDI
Identifiers
- Catalog Number
- CERVP1240 FDA UDI
- Primary DI / UDI-DI
- 07290110206901 FDA UDI
- 510(k) Number
- K200883 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
- Length — 24 Millimeter FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
CarboClear Cervical Plate System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
- Zavation — ZAVATION · Class II
- Cervalign — Xtant Medical Holdings, Inc. · Class II
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K200883 also covers:
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Cervical Plate 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carbofix Orthopedics Ltd
Sources (1)
- FDA UDI 0f90b424-6406-4918-857e-3df3652c5cd8 37 fields · synced Jun 8, 2026