DEVICE: V40 Head (07613327012958)
Device Identifier (DI) Information
V40 Head
6260-5-428
In Commercial Distribution
6260-5-428
Howmedica Osteonics Corp.
6260-5-428
In Commercial Distribution
6260-5-428
Howmedica Osteonics Corp.
V40 Femoral Head
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? |
---|---|---|---|---|
33175 | Metallic femoral head prosthesis |
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
KWL | Prosthesis, hip, hemi-, femoral, metal |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
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 |
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: Offset: 12.0 Millimeter |
Outer Diameter: 28.0 Millimeter |
Device Record Status
f82357e9-e51f-4426-a5bc-351c75595ef6
December 20, 2023
4
September 24, 2015
December 20, 2023
4
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