DEVICE: Corin Bipolar Prosthesis (05055196979437)

Device Identifier (DI) Information

Corin Bipolar Prosthesis
111.947
In Commercial Distribution
111.947
CORIN LTD
05055196979437
GS1

1
295437313 *Terms of Use
26mm Bipolar Semi Assembled
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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
Femoral head bipolar component A sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.
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FDA Product Code

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Product Code Product Code Name
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K925897 000
No CLOSE

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

f3b5778d-b75e-4ee5-92d9-82593c85d084
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)

[?]
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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