CarboClear Pedicle Screw System PPS922940

GUDID 07290110204686

Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.

CARBOFIX ORTHOPEDICS LTD

Orthopaedic implant inserter/extractor, reusable
Primary Device ID07290110204686
NIH Device Record Key2bcc7b0f-612a-47f8-a49d-23a72be7c4ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarboClear Pedicle Screw System
Version Model NumberExtractor
Catalog NumberPPS922940
Company DUNS649185170
Company NameCARBOFIX ORTHOPEDICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com
Phone+97299511511
Emailinfo@carbo-fix.com

Device Dimensions

Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter
Lumen/Inner Diameter6.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110204686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

[07290110204686]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-10-29
Device Publish Date2018-07-23

On-Brand Devices [CarboClear Pedicle Screw System]

07290110205041Gauge for use with the CarboClear Pedicle Screw System trans-connectors.
07290110205034Wrench for use with the CarboClear Pedicle Screw System trans-connectors unlocker.
07290110205027Unlocker for use with the CarboClear Pedicle Screw System trans-connectors.
07290110205010Locking Device for use with the CarboClear Pedicle Screw System trans-connectors.
17290110204874Curved Rod (oncology) of the CarboClear Pedicle Screw System
17290110204867Curved Rod (oncology) of the CarboClear Pedicle Screw System
17290110204850Curved Rod (oncology) of the CarboClear Pedicle Screw System
17290110204843Curved Rod (oncology) of the CarboClear Pedicle Screw System
17290110204836Curved Rod (oncology) of the CarboClear Pedicle Screw System
17290110204829Straight Rod (oncology) of the CarboClear Pedicle Screw System
17290110204812Straight Rod (oncology) of the CarboClear Pedicle Screw System
17290110204805Straight Rod (oncology) of the CarboClear Pedicle Screw System
17290110204799Straight Rod (oncology) of the CarboClear Pedicle Screw System
07290110204785Straight Rod (oncology) of the CarboClear Pedicle Screw System
07290110204778Rod cutting instruments for use with the CarboClear Pedicle Screw System.
07290110204761Non cannulated pedicle screw (oncology)
17290110204751Non cannulated pedicle screw (oncology)
07290110204747Mallet for use with the CarboClear Pedicle Screw System.
07290110204730Distraction device for use with the CarboClear Pedicle Screw System.
07290110204723Rod End Shaper for use with the CarboClear Pedicle Screw System.
07290110204716Saw for use with the CarboClear Pedicle Screw System.
07290110204709Compression device for use with the CarboClear Pedicle Screw System.
07290110204693Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.
07290110204686Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.
07290110204679Pedicle Screw Extractor for use with the CarboClear Pedicle Screw System.
07290110204662Unlocker for use with the CarboClear Pedicle Screw System.
07290110204655Locking Element positioning device for use with the CarboClear Pedicle Screw System.
07290110204648Unlocker for use with the CarboClear Pedicle Screw System.
07290110204631Sterilization case for use with the CarboClear Pedicle Screw System.
07290110204624Container for use with the CarboClear Pedicle Screw System.
07290110202200Iliac Crest Rod of the CarboClear Pedicle Screw System
07290110202002Template for use with the CarboClear Pedicle Screw System.
07290110201982Template for use with the CarboClear Pedicle Screw System.
07290110201975Template for use with the CarboClear Pedicle Screw System.
07290110201968Template for use with the CarboClear Pedicle Screw System.
17290110201958Trans-Connector Locking Element (and Ring) for use as part of the CarboClear Pedicle Screw Syste
17290110201941Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201934Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201927Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201910Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201903Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201897Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201880Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201873Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201866Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201859Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201842Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201835Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201828Trans-Connector Rod of the CarboClear Pedicle Screw System
17290110201811Trans-Connector Rod of the CarboClear Pedicle Screw System
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.