DEVICE: Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis (05055196903630)

Device Identifier (DI) Information

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis
S279.846
In Commercial Distribution
S279.846
CORIN LTD
05055196903630
GS1

1
295437313 *Terms of Use
MODULAR INTRODUCER BASE PLATE SIZE 2/46-48mm
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47847 Orthopaedic implant-instrument extension adaptor, reusable
A connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KXA Prosthesis, hip, femoral, resurfacing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K994153 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

f4f54dc0-a5f5-4b16-9a7c-3140553f58d6
May 03, 2023
4
August 17, 2016
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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

[?]
+441285659866 2203
lucinda.gerber@coringroup.com
+441285659866 2118
rachel.king@coringroup.com
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