Identity
- Trade Name
- CarboClear Pedicle Screw System FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Device Name
- Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System. FDA UDI
- Model / Reference
- Extractor FDA UDI
- Description
- Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System. FDA UDI
Identifiers
- Catalog Number
- PPS922940 FDA UDI
- Primary DI / UDI-DI
- 07290110205737 FDA UDI
- 510(k) Number
- K173487 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use 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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 6.5 Millimeter FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, single-use
CarboClear Pedicle Screw System by Carbofix Orthopedics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.
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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 |
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Manufacturer
- Manufacturer
- Carbofix Orthopedics Ltd
Sources (1)
- FDA UDI d9318c10-a469-4465-8a39-c935e4aa55d8 37 fields · synced May 30, 2026