DEVICE: CarboClear X Pedicle Screw System (07290117350003)
Device Identifier (DI) Information
CarboClear X Pedicle Screw System
Rod Reducer
In Commercial Distribution
PPS922440G2
CARBOFIX ORTHOPEDICS LTD
Rod Reducer
In Commercial Distribution
PPS922440G2
CARBOFIX ORTHOPEDICS LTD
Tulip Adjuster for use with the CarboClear X Pedicle Screw System.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47554 | Orthopaedic counter-torque/rod-pushing instrument |
A hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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NKB | Thoracolumbosacral Pedicle Screw System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K210716 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
410f953f-4321-490b-91e8-89a9dd8a7f86
July 08, 2021
1
June 30, 2021
July 08, 2021
1
June 30, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-408-0120
usa@carbo-fix.com +97299511511
info@carbo-fix.com
usa@carbo-fix.com +97299511511
info@carbo-fix.com