Identity
- Trade Name
- CarboClear X Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic instrument surgical connector FDA UDI
- Device Name
- Part of the CarboClear X Pedicle Screw System - MIS Supplemental Set. FDA UDI
- Model / Reference
- MIS Screw Tube FDA UDI
- Description
- Part of the CarboClear X Pedicle Screw System - MIS Supplemental Set. FDA UDI
Identifiers
- Catalog Number
- MIS008 FDA UDI
- Primary DI / UDI-DI
- 07290117350799 FDA UDI
- 510(k) Number
- K231280 FDA UDI
- FDA Product Code
- NKB FDA UDIOLO FDA UDIPML FDA UDI
- GMDN Term
- Orthopaedic instrument surgical connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI882.4560 FDA UDI888.3027 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: Orthopaedic instrument surgical connector
CarboClear X Pedicle Screw System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic instrument surgical connector.
- Surgical Instrument — Jeil Medical Corporation · Class I
- Maxim® Instrumentation — Biomet Orthopedics, Inc. · Class I
- QUANTUM — IN2BONES · Class I
- KINCISE™ System Acetabular Cup Extraction SST Head 28mm — Spierings Orthopaedics B.V. · Class I
- Solstice Occipito-Cervico-Thoracic System — Life Spine, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- Pilot Spinal System — Life Spine, Inc. · Class II
- MIS Curved Rod, Ø5.5 x 85mm — Captiva Spine · Class II
Cleared under the same submission
K231280 also covers:
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw Systems — 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 e791f634-5e1f-4731-b6fd-07fe0cd1f3bb 36 fields · synced Jun 1, 2026