DEVICE: Trident (04546540516848)
Device Identifier (DI) Information
Trident
625-0T-32E
In Commercial Distribution
625-0T-32E
Howmedica Osteonics Corp.
625-0T-32E
In Commercial Distribution
625-0T-32E
Howmedica Osteonics Corp.
Alpha Code E
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? |
|---|---|---|---|---|
| 48055 | Ceramic acetabular liner |
A sterile implantable inner component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of ceramic material (e. g alumina).
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MRA | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P000013 | 001 |
| P000013 | 002 |
| P000013 | 003 |
| P000013 | 004 |
| P000013 | 005 |
| P000013 | 006 |
| P000013 | 008 |
| P000013 | 009 |
| P000013 | 010 |
| P000013 | 011 |
| P000013 | 012 |
| P000013 | 013 |
| P000013 | 014 |
| P000013 | 015 |
| P000013 | 016 |
| P000013 | 017 |
| P000013 | 018 |
| P000013 | 019 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Lumen/Inner Diameter: 32.0 Millimeter |
| Device Size Text, specify: Degree: 0.0 Degree |
Device Record Status
7c880dd1-839d-406f-9b53-912933807ae7
March 14, 2022
9
October 03, 2014
March 14, 2022
9
October 03, 2014
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 |
|---|---|
| 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
[?]
No Customer Contact currently defined