DEVICE: Trident (07613327025590)
Device Identifier (DI) Information
Trident
690-00-32I
In Commercial Distribution
690-00-32I
Howmedica Osteonics Corp.
690-00-32I
In Commercial Distribution
690-00-32I
Howmedica Osteonics Corp.
Constrained Acetabular Insert
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
34076 | Polyethylene acetabulum prosthesis |
A sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of polyethylene (polyethylene cup); it may include fixation devices (e.g., screws) for attachment to the body.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K061654 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Alpha Code: I |
Device Record Status
36cd1b26-d6a9-4a4f-bf4b-28be55d56220
June 24, 2022
4
September 24, 2015
June 24, 2022
4
September 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 |
---|---|
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