DEVICE: RIGI-FIX Series II (05051693301238)
Device Identifier (DI) Information
RIGI-FIX Series II
Uncemented Hip Stem - Size 3 (134 x 7.5mm)
In Commercial Distribution
HS1455
IMPLANTS INTERNATIONAL LTD
Uncemented Hip Stem - Size 3 (134 x 7.5mm)
In Commercial Distribution
HS1455
IMPLANTS INTERNATIONAL LTD
Uncemented Hip Stem for Press Fit Applications - Size 3 (134 x 7.5mm) (12/14 Taper)
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33581 | Coated hip femur prosthesis, modular |
A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined 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 |
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room temperature and Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 134 Millimeter |
Device Record Status
4f0639e8-60cb-48ce-a5d5-a4a295ebe01e
March 29, 2018
2
July 31, 2016
March 29, 2018
2
July 31, 2016
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
[?]
+4401642769080
michael.russon@implantsinternational.com +4401642769080
mohan.emmanuel@implantsinternational.com +4401642769080
enquiries@implantsinternational.com
michael.russon@implantsinternational.com +4401642769080
mohan.emmanuel@implantsinternational.com +4401642769080
enquiries@implantsinternational.com