DEVICE: RING-LOK (05051693307681)
Device Identifier (DI) Information
RING-LOK
Modular Bi-Polar (58mm- 28mm Head)
In Commercial Distribution
BP2378
IMPLANTS INTERNATIONAL LTD
Modular Bi-Polar (58mm- 28mm Head)
In Commercial Distribution
BP2378
IMPLANTS INTERNATIONAL LTD
Modular Bi-Polar 58mm Dia. (28mm Head) For Uncemented Applications
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? |
---|---|---|---|---|
33175 | Metallic femoral head prosthesis |
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA), or articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K132539 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room temperature and Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 58 Millimeter |
Device Record Status
ea266f7a-3d05-4e2e-83e5-45141b28ea3a
April 08, 2024
4
July 31, 2016
April 08, 2024
4
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
mohan.emmanuel@implantsinternational.com +4401642769080
enquiries@implantsinternational.com +4401642769080
michael.russon@implantsinternational.com
mohan.emmanuel@implantsinternational.com +4401642769080
enquiries@implantsinternational.com +4401642769080
michael.russon@implantsinternational.com