DEVICE: Secur-Fit (07613327020885)
Device Identifier (DI) Information
Secur-Fit
6054-1016S
In Commercial Distribution
6054-1016S
Howmedica Osteonics Corp.
6054-1016S
In Commercial Distribution
6054-1016S
Howmedica Osteonics Corp.
127 Degree Neck Angle Hip Stem
Device Characteristics
MR Conditional | |
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 |
---|---|
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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K041170 | 000 |
K051738 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Taper Connection: C-TPR |
Device Size Text, specify: Stem Length: 160.0 Millimeter |
Device Size Text, specify: Neck Length: 35.0 Millimeter |
Device Size Text, specify: Size: 10 |
Device Record Status
e6e7e9c9-490b-4ee9-9aca-1e900c9ecbd9
June 26, 2023
5
September 24, 2015
June 26, 2023
5
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