DEVICE: Zyranox Zirconia Ceramic Femoral Heads (05055196928749)

Device Identifier (DI) Information

Zyranox Zirconia Ceramic Femoral Heads
E064.232
In Commercial Distribution
E064.232
CORIN LTD
05055196928749
GS1

1
295437313 *Terms of Use
ZIRCONIA MOD HEAD LONG 32mm Eurocone Taper
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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. 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?
38156 Ceramic femoral head prosthesis
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K992235 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Radiation 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

cfdf180d-5b72-4370-b4f4-29f9e401b8cb
September 09, 2020
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

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

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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