DEVICE: BioBall™ 7.5° Offset Adapter (04048266025586)
Device Identifier (DI) Information
BioBall™ 7.5° Offset Adapter
12/14 XL
Not in Commercial Distribution
HM30224
Merete GmbH
12/14 XL
Not in Commercial Distribution
HM30224
Merete GmbH
TiAl6V4 ELI sterile
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? |
---|---|---|---|---|
59688 | Femoral head/stem prosthesis adaptor |
A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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: 12/14, Neck length: XL |
Device Record Status
3d958444-4348-4a82-bae9-d074df7f1caa
May 12, 2023
8
October 15, 2015
May 12, 2023
8
October 15, 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 |
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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(630)869-1092
service@merete-medical.com
service@merete-medical.com