DEVICE: Restoration (04546540638854)
Device Identifier (DI) Information
Restoration
1235-2-622
In Commercial Distribution
1235-2-622
Howmedica Osteonics Corp.
1235-2-622
In Commercial Distribution
1235-2-622
Howmedica Osteonics Corp.
ADM- Cup w/HA
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? |
---|---|---|---|---|
43167 | Acetabular shell |
An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
KWL | Prosthesis, hip, hemi-, femoral, metal |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
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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Outer Diameter: 62.0 Millimeter |
Device Size Text, specify: Side: LEFT |
Device Record Status
ba8846c5-3aff-450e-b307-03fad9b9d780
October 13, 2021
4
September 24, 2015
October 13, 2021
4
September 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 |
---|---|
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
[?]
No Customer Contact currently defined