DEVICE: CarboClear X Pedicle Screw System (07290117350881)

Device Identifier (DI) Information

CarboClear X Pedicle Screw System
MIS Rod Feeler
In Commercial Distribution
MIS027
CARBOFIX ORTHOPEDICS LTD
07290117350881
GS1

1
649185170 *Terms of Use
Part of the CarboClear X Pedicle Screw System - MIS Supplemental Set.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

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?
47870 Orthopaedic fixation implant alignment tool
A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NKB Thoracolumbosacral Pedicle Screw System
OLO Orthopedic Stereotaxic Instrument
PML Bone Cement, Posterior Screw Augmentation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K231280 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

dc91e643-a2e5-4923-83d4-e8a49a918ba2
September 21, 2023
1
September 13, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+97299511511
info@carbo-fix.com
1-800-408-0120
usa@carbo-fix.com
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