DEVICE: Trident (07613153073079)
Device Identifier (DI) Information
Trident
502-01-50D
In Commercial Distribution
502-01-50D
Howmedica Osteonics Corp.
502-01-50D
In Commercial Distribution
502-01-50D
Howmedica Osteonics Corp.
Hemispherical Acetabular Shell
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? |
|---|---|---|---|---|
| 43167 | Acetabular shell |
An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Outer Diameter: 50.0 Millimeter |
| Device Size Text, specify: Alpha Code: D |
Device Record Status
5af90c9c-be24-41fe-88bc-023a950555a9
September 09, 2020
3
September 24, 2015
September 09, 2020
3
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