DEVICE: Conformity stem, collared, #7 (04711605583008)
Device Identifier (DI) Information
Conformity stem, collared, #7
1110-1007
In Commercial Distribution
1110-1007
UNITED ORTHOPEDIC CORP.
1110-1007
In Commercial Distribution
1110-1007
UNITED ORTHOPEDIC CORP.
Conformity stem, collared, #7
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
33181 | Metal-on-polyethylene total hip prosthesis |
A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
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Active | true |
34032 | Revision coated hip femur prosthesis |
A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
|
Active | true |
33581 | Coated hip femur prosthesis, modular |
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K183312 | 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
d7b589dd-e7cf-481c-9e56-61df59d69891
September 04, 2019
1
August 27, 2019
September 04, 2019
1
August 27, 2019
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+886 0229294567
service@uoc.com.tw
service@uoc.com.tw