DEVICE: Stability (05051693300576)
Device Identifier (DI) Information
Stability
Flanged Cemented Hip Stem - Size 1
In Commercial Distribution
HS1220
IMPLANTS INTERNATIONAL LTD
Flanged Cemented Hip Stem - Size 1
In Commercial Distribution
HS1220
IMPLANTS INTERNATIONAL LTD
Flanged Cemented Hip Stem - Size 1 - 155mm long (Cobalt Chrome)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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34203 | Uncoated femoral stem prosthesis, modular |
A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.
|
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 [?] |
---|---|
K910836 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Room temperature and Dry |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 155 Millimeter |
Device Record Status
d5e82c10-b990-4164-b51d-b832e169e749
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