DEVICE: BIOLOX DELTA (08033390007252)
Device Identifier (DI) Information
BIOLOX DELTA
Femoral Head
In Commercial Distribution
5010.42.363
LIMACORPORATE SPA
Femoral Head
In Commercial Distribution
5010.42.363
LIMACORPORATE SPA
Biolox Delta Head 36mm #L
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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? |
|---|---|---|---|---|
| 38156 | Ceramic femoral head prosthesis |
An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). 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 with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.
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Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K141327 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: D=36mm L |
Device Record Status
831e10d0-2d26-46b0-b6e2-54856bc7fe14
September 09, 2020
4
July 31, 2015
September 09, 2020
4
July 31, 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