DEVICE: Ceramic Femoral Head BIOLOX® Forte 12/14L (04712602341646)
Device Identifier (DI) Information
Ceramic Femoral Head BIOLOX® Forte 12/14L
1203-1428
In Commercial Distribution
1203-1428
UNITED ORTHOPEDIC CORP.
1203-1428
In Commercial Distribution
1203-1428
UNITED ORTHOPEDIC CORP.
Ceramic Femoral Head, O.D.φ28mm, 12/14- L
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33715 | Ceramic-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 ceramic-on-polyethylene or cross-linked polyethylene (PE) 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 |
34204 | Ceramic-on-ceramic 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 ceramic-on-ceramic interface. 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, Calicum-Phosphate |
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K103497 | 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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Outer Diameter: 28 Millimeter |
Device Record Status
54a671a5-e49d-4c82-86cd-bc87b7d3560f
August 03, 2018
4
October 24, 2015
August 03, 2018
4
October 24, 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 |
---|---|---|---|---|---|
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
[?]
+886229294567
service@uoc.com.tw
service@uoc.com.tw