DEVICE: MINIMA S (08033390079181)

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Device Record History
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Device Identifier (DI) Information
MINIMA S
Uncemented Stem
In Commercial Distribution
4504.21.070
LIMACORPORATE SPA
08033390079181
GS1

1
432066322 *Terms of Use
Minima S femoral stem lateralizing #7
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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?
34191 Coated femoral stem prosthesis, modular
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K141327 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Lat #7
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Device Record Status
7a28ca21-eac6-434b-a42c-700699789f22
July 06, 2018
3
July 31, 2015
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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