DEVICE: Restoration (04546540642967)
Device Identifier (DI) Information
Restoration
6276-6-115
In Commercial Distribution
6276-6-115
Howmedica Osteonics Corp.
6276-6-115
In Commercial Distribution
6276-6-115
Howmedica Osteonics Corp.
Modular Hip System
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? |
|---|---|---|---|---|
| 38155 | Press-fit femoral stem prosthesis |
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
| KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
| KWL | Prosthesis, hip, hemi-, femoral, metal |
| LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
| MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
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: Distal Diameter: 15.0 Millimeter |
| Device Size Text, specify: Stem Length: 167.0 Millimeter |
Device Record Status
f8fed7ca-5fa2-457a-8bf7-c39910ba3c3c
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