DEVICE: Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis (05055343887448)
Device Identifier (DI) Information
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis
S299.742
In Commercial Distribution
S299.742
CORIN LTD
S299.742
In Commercial Distribution
S299.742
CORIN LTD
ACETABULAR REAMER 42MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
32848 | Acetabular orthopaedic reamer |
An orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KXA | Prosthesis, hip, femoral, resurfacing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K994153 | 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
d6e3f2ef-efb2-4f41-bd66-4ffb7a26e822
July 06, 2018
3
August 17, 2016
July 06, 2018
3
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