Identity
- Trade Name
- CarboClear Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw head/rod adaptor FDA UDI
- Device Name
- Trans-Connector Locking Element (and Ring) for use as part of the CarboClear Pedicle Screw System FDA UDI
- Model / Reference
- Trans-Connector Locking Element + Ring FDA UDI
- Description
- Trans-Connector Locking Element (and Ring) for use as part of the CarboClear Pedicle Screw System FDA UDI
Identifiers
- Catalog Number
- PPSTCC4000 FDA UDI
- Primary DI / UDI-DI
- 07290110201951 FDA UDI
- 510(k) Number
- K182377 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw head/rod adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
Category: Spinal bone screw head/rod adaptor
CarboClear Pedicle Screw System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw head/rod adaptor.
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- TAURUS — CTL Medical Corporation · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
- Vertefix — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
Cleared under the same submission
K182377 also covers:
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD
- CarboClear Pedicle Screw 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 a10f566c-187e-4daa-9847-7e22a6632af1 36 fields · synced May 30, 2026