DEVICE: Trident (04546540259936)
Device Identifier (DI) Information
Trident
625-0T-36I
In Commercial Distribution
625-0T-36I
Howmedica Osteonics Corp.
625-0T-36I
In Commercial Distribution
625-0T-36I
Howmedica Osteonics Corp.
Alpha Code I
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 |
---|
Device Size Text, specify: Degree: 0.0 Degree |
Lumen/Inner Diameter: 36.0 Millimeter |
Device Record Status
5b68d2b0-6aa9-46df-9ed6-1051ed31abc5
March 14, 2022
9
October 09, 2015
March 14, 2022
9
October 09, 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 |
---|---|
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