DEVICE: Cormet (05055196904675)

Device Identifier (DI) Information

Cormet
479.046
Not in Commercial Distribution
479.046
CORIN LTD
05055196904675
GS1
October 15, 2014
1
295437313 *Terms of Use
Cormet resurfacing head - 46mm size 5 cemented
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Resurfacing hip prosthesis A sterile implantable artificial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is typically used to replace parts of the hip damaged by degenerative joint diseases (e.g., arthritis, avascular necrosis) and is commonly used for younger/active patients to avoid total hip replacements/revisions.
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FDA Product Code

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Product Code Product Code Name
NXT Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P050016 010
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

3b0337a4-ed05-44b8-9f07-4fdff40f0ca5
July 06, 2018
3
October 14, 2014
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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