DEVICE: B-P TOTAL HIP SYSTEM (00814193023070)
Device Identifier (DI) Information
B-P TOTAL HIP SYSTEM
01-03-0047
Not in Commercial Distribution
01-03-0047
ENDOTEC, INC.
01-03-0047
Not in Commercial Distribution
01-03-0047
ENDOTEC, INC.
B-P HIP FEMORAL RESURFACING CUP W/BIOCOAT & W/ULTRACOAT - 47 MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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33717 | Resurfacing metallic hip prosthesis |
An implantable partial 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; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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KXA | Prosthesis, Hip, Femoral, Resurfacing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K904870 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 5 and 40 Degrees Celsius |
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 47 Millimeter |
Device Record Status
5f4c8519-7d6c-4517-82ae-00c25caa2617
April 18, 2024
7
September 17, 2015
April 18, 2024
7
September 17, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined