DEVICE: Kinos Axiom Instrumentation (00840097509501)

Device Identifier (DI) Information

Kinos Axiom Instrumentation
5801-0021
In Commercial Distribution
5801.0021
Restor3d, Inc.
00840097509501
GS1

1
080819836 *Terms of Use
2.4mm K-Wire with Stop, Non-Sterile
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
61781 Joint prosthesis implantation kit, single-use
A collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K192778 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

e719f94f-0d4a-448d-b60d-0400edbd9c62
November 02, 2023
2
July 18, 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

[?]
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

[?]
No Customer Contact currently defined
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