DEVICE: Accolade (07613327020724)
Device Identifier (DI) Information
Accolade
6058-0230D
In Commercial Distribution
6058-0230D
Howmedica Osteonics Corp.
6058-0230D
In Commercial Distribution
6058-0230D
Howmedica Osteonics Corp.
132 Degree Cemented Hip Stem
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? |
|---|---|---|---|---|
| 34190 | Uncoated hip femur prosthesis, modular |
A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
| 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 |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
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: Neck Length: 30.0 Millimeter |
| Device Size Text, specify: Stem Length: 124.0 Millimeter |
| Device Size Text, specify: Size: 2 |
| Device Size Text, specify: Taper Connection: V40? |
Device Record Status
2cfcabd9-c0f8-4295-bdaa-efee08877912
March 29, 2018
2
September 24, 2015
March 29, 2018
2
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