DEVICE: Trinity No Hole Shells (05055343866528)

Device Identifier (DI) Information

Trinity No Hole Shells
321.04.058
In Commercial Distribution
321.04.058
CORIN LTD
05055343866528
GS1

1
295437313 *Terms of Use
Trinity No Hole Shell Ø58mm Taper Size 4
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Acetabular shell A sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.
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FDA Product Code

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Product Code Product Code Name
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
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 [?]
K130128 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Radiation Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

b4baddaf-22d7-4c07-ad58-da6546f2c42f
July 06, 2018
3
August 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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