iDuo® iPoly™ Insert Kit
- Primary DI
- M572RBK0100600021
- Brand
- iDuo® iPoly™ Insert Kit
- Company
- Conformis, Inc.
- Model
- RBK010060002
- Catalog number
- RBK0100600
- Device description
- N/A
- Published
- 2015-10-26
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| OOG | Knee Arthroplasty Implantation System |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 2 |
| OOG | Knee Arthroplasty Implantation System | Orthopedic | 2 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| M572RBK0100600021 | Primary | HIBCC | 0 | |
Device Sizes#
Type, Value, Unit table| Type | Value | Unit |
|---|
| Height | 6 | Millimeter |
Regulatory Flags#
- DUNS number
- 808821883
- Device count
- 1
- Kit
- true
- Serial number
- true
- Expiration date on label
- true
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| 00850268007194 | iTotal® Impactor Head | 1080-535 | | 2016-10-24 |
| 00850268007200 | iTotal® CR Tibial Tray Impactor Tip | 1080-536 | | 2016-10-24 |
| 00850268007217 | iTotal® PS Tibial Tray Impactor Tip | 1080-542 | | 2016-10-24 |
| 00850268007224 | iTotal® Poly Impactor Tip | 1080-524 | | 2016-10-24 |
| M572HDL060C24S011 | iTotal® Hip Replacement System | HDL060C24S01 | HDL060C24S | 2018-08-06 |
| M572HDL060D24S011 | iTotal® Hip Replacement System | HDL060D24S01 | HDL060D24S | 2018-07-30 |
| M572HDL060D34S011 | iTotal® Hip Replacement System | HDL060D34S01 | HDL060D34S | 2018-08-06 |
| M572HDL060E24S011 | iTotal® Hip Replacement System | HDL060E24S01 | HDL060E24S | 2018-08-06 |
| M572HDL060E34S011 | iTotal® Hip Replacement System | HDL060E34S01 | HDL060E34S | 2018-08-06 |
| M572HDL060F24S011 | iTotal® Hip Replacement System | HDL060F24S01 | HDL060F24S | 2018-08-06 |
| M572HDL060F34S011 | iTotal® Hip Replacement System | HDL060F34S01 | HDL060F34S | 2018-08-06 |
| M572HDL060C10S011 | iTotal® Hip Replacement System | HDL060C10S01 | HDL060C10S | 2018-08-06 |
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