Identity
- Trade Name
- CarboClear Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic implantable-device cutter FDA UDI
- Device Name
- Saw for use with the CarboClear Pedicle Screw System. FDA UDI
- Model / Reference
- Saw FDA UDI
- Description
- Saw for use with the CarboClear Pedicle Screw System. FDA UDI
Identifiers
- Catalog Number
- PPS925120US FDA UDI
- Primary DI / UDI-DI
- 07290110204716 FDA UDI
- 510(k) Number
- K173487 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Orthopaedic implantable-device cutter 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic implantable-device cutter
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 Orthopaedic implantable-device cutter.
- Tecomet — Tecomet,Inc · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- Tecomet — Tecomet,Inc · Class I
- BOLT/NUT SET — SONTEC INSTRUMENTS, INC. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- PLUG CUTTER — SONTEC INSTRUMENTS, INC. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
Cleared under the same submission
K173487 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 29668677-a851-4062-8103-750c22797595 36 fields · synced May 30, 2026