DEVICE: Corin Bipolar Prosthesis (05055196924758)
Device Identifier (DI) Information
Corin Bipolar Prosthesis
111.952
In Commercial Distribution
111.952
CORIN LTD
111.952
In Commercial Distribution
111.952
CORIN LTD
26mm Bipolar Semi Assembled
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33695 | Bipolar femoral head outer component, hemiarthroplasty |
An 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., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K925897 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cc9fd730-9620-41f4-a167-3b72c5638f2e
September 09, 2020
4
August 17, 2016
September 09, 2020
4
August 17, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441285659866
2118
rachel.king@coringroup.com +441285659866 2203
lucinda.gerber@coringroup.com
rachel.king@coringroup.com +441285659866 2203
lucinda.gerber@coringroup.com