DEVICE: INSTRUMENT (07613327215441)
Device Identifier (DI) Information
INSTRUMENT
2260-36H
In Commercial Distribution
2260-36H
Howmedica Osteonics Corp.
2260-36H
In Commercial Distribution
2260-36H
Howmedica Osteonics Corp.
TRIDENT ELEVATED RIM INSERT TRIAL
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| 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? |
|---|---|---|---|---|
| 58480 | Acetabulum prosthesis trial, prefabricated, reusable |
A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HWC | Screw, fixation, bone |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, 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 |
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 |
|---|
| Device Size Text, specify: Alpha Code: H |
| Lumen/Inner Diameter: 36.0 Millimeter |
Device Record Status
8bc0c8ec-d519-4fbb-adfe-19730f47b273
April 28, 2022
6
September 24, 2016
April 28, 2022
6
September 24, 2016
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