DEVICE: Restoration (07613327018752)

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Device Record History
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Device Identifier (DI) Information
Restoration
6522-0610
In Commercial Distribution
6522-0610
Howmedica Osteonics Corp.
07613327018752
GS1

1
058311945 *Terms of Use
Hip Stem
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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?
34032 Revision coated hip femur prosthesis
A sterile device designed to replace the entire femoral component of a total hip prosthesis implanted during replacement of the total hip prosthesis typically due to wear. The revision device is composed of two or more separate segments (e.g., femoral head, neck, stem, and extensions) designed to be joined (modular) and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. 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
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K993077 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

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Size Type Text
Device Size Text, specify: Stem Length: 145.0 Millimeter
Device Size Text, specify: Taper Connection: C-TPR
Device Size Text, specify: Size: 6
Device Size Text, specify: Neck Length: 25.0 Millimeter
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Device Record Status
dd2791b8-7f30-46dc-9c40-9f3d6e650b09
July 06, 2018
3
September 24, 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

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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

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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