DEVICE: Restoration (07613327012583)
Device Identifier (DI) Information
Restoration
504-02-76H-R
In Commercial Distribution
504-02-76H-R
Howmedica Osteonics Corp.
504-02-76H-R
In Commercial Distribution
504-02-76H-R
Howmedica Osteonics Corp.
Anatomic Hemispherical Shell
Device Characteristics
MR Conditional | |
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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142462 | 000 |
K151264 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Side: RIGHT |
Device Size Text, specify: Alpha Code: H |
Outer Diameter: 76.0 Millimeter |
Device Record Status
fa19b98f-31ee-4034-b97e-bc0ef3679921
July 29, 2022
5
September 24, 2015
July 29, 2022
5
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