DEVICE: INVISION (00889797076586)
Device Identifier (DI) Information
INVISION
60004403
In Commercial Distribution
60004403
WRIGHT MEDICAL TECHNOLOGY, INC.
60004403
In Commercial Distribution
60004403
WRIGHT MEDICAL TECHNOLOGY, INC.
No description.
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? |
---|---|---|---|---|
33718 | Fixed-bearing total ankle prosthesis |
A sterile implantable artificial substitute for an ankle joint designed to replace the main articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes tibial and talar components typically with parts made of metal and polyethylene (PE); the PE bearing that articulates the two components is attached or moulded to one of the components. Fixation devices (e.g., screws) for implantation may be included and implantation may be performed with or without bone cement.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142117 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: +4 Millimeter |
Device Size Text, specify: Extra Long |
Device Size Text, specify: Size: 4 |
Device Record Status
48f1a171-ac2f-4a3b-b5cb-2587b522773a
June 08, 2022
1
May 31, 2022
June 08, 2022
1
May 31, 2022
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
[?]
+1(800)238-7117
customerservice@wmt.com
customerservice@wmt.com