DEVICE: NA (20886982078176)
Device Identifier (DI) Information
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? |
|---|---|---|---|---|
| 32847 | Implantable bone nut |
A small, implantable block threaded on its inside surface designed to be threaded outside a bone bolt or screw (not included) for secure fastening/stabilisation. It is not intended to be internally threaded to the bolt/screw (i.e., it is not a set screw). It is made of metallic or non-metallic materials. This is a single-use device.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K051600 | 000 |
| K092190 | 000 |
| K161417 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6f658a8d-9173-4f85-b77a-c20a058c821f
July 14, 2025
5
September 14, 2015
July 14, 2025
5
September 14, 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 |
|---|---|
| HIBCC | H67903311061100 |
Unit of Use DI
[?]
Unit of Use DI Number:
80886982078178
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx