DEVICE: Rim-Fix (05051693309067)
Device Identifier (DI) Information
Rim-Fix
Poly Liner 10° Hood 60 x 36mm
In Commercial Distribution
AL3988
IMPLANTS INTERNATIONAL LTD
Poly Liner 10° Hood 60 x 36mm
In Commercial Distribution
AL3988
IMPLANTS INTERNATIONAL LTD
Poly Liner 10° Hood 60 x 36mm (UHMWPE) Uncemented
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? |
---|---|---|---|---|
44362 | Constrained polyethylene acetabular liner |
A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K993713 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room Temperature and Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 60 Millimeter |
Device Record Status
e07f4834-0e70-42d3-86d8-689523d6f20c
April 08, 2024
3
July 31, 2016
April 08, 2024
3
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