DEVICE: INSTRUMENT (07613327208191)
Device Identifier (DI) Information
INSTRUMENT
1020-3240
In Commercial Distribution
1020-3240
Howmedica Osteonics Corp.
1020-3240
In Commercial Distribution
1020-3240
Howmedica Osteonics Corp.
ACCOLADE NECK 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? |
|---|---|---|---|---|
| 58481 | Femoral stem prosthesis trial |
A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| 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 |
| HWC | Screw, fixation, bone |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-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 |
|---|
| Device Size Text, specify: Degree: 132.0 Degree |
| Device Size Text, specify: Diameter: 40.0 Millimeter |
Device Record Status
1b18d61f-f941-41fc-985b-b6c853c4d3cc
December 26, 2022
5
September 24, 2016
December 26, 2022
5
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