DEVICE: MAESTRO TOTAL WRIST (00880304555082)
Device Identifier (DI) Information
MAESTRO TOTAL WRIST
180414
In Commercial Distribution
180414
Biomet Orthopedics, LLC
180414
In Commercial Distribution
180414
Biomet Orthopedics, LLC
No description.
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? |
---|---|---|---|---|
33370 | Total wrist radius prosthesis |
An implantable device designed to replace the distal end of the radius as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and consists of a stem and articulating surface, and may interface with a spacer. Fixation devices for implantation (e.g., screws) may be included with the prosthesis and implantation may be performed with or without bone cement.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JWJ | PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K080426 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: SIZE 1 16MM HEIGHT |
Device Record Status
f7222cb7-ccd4-4b8e-baf2-021911d107a3
May 30, 2025
5
October 24, 2015
May 30, 2025
5
October 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 |
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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)348-9500
customerservice@zimmerbiomet.com
customerservice@zimmerbiomet.com