ATTUNE
- Primary DI
- 10603295416289
- Brand
- ATTUNE
- Company
- DEPUY (IRELAND)
- Model
- 1506-11-006
- Catalog number
- 150611006
- Device description
- Attune Knee System TIBIAL BASE POROCOAT ROTATING PLATFORM SIZE 6 CEMENTLESS
- Published
- 2016-10-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
xx.xxProduct Codes#
| Code | Name |
|---|---|
| NJL | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P830055 | 172 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10603295416289 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10603295416289 | 10603295416289 |
GMDN Terms#
| Term | Definition |
|---|---|
| Coated knee tibia prosthesis | A sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)255-2500 | xx@xx.xx |
Regulatory Flags#
- DUNS number
- 989365556
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10603295168324 | SMARTSET | 3092-020 | 3092020 | 2015-09-24 |
| 10603295168331 | SMARTSET | 3092-040 | 3092040 | 2015-09-24 |
| 10603295168614 | NA | 3312-040 | 3312040 | 2015-09-24 |
| 10603295168621 | NA | 3322-020 | 3322020 | 2015-09-24 |
| 10603295168638 | NA | 3332-040 | 3332040 | 2015-09-24 |
| 10603295005438 | GLOBAL AP | 1130-02-000 | 113002000 | 2015-09-24 |
| 10603295218289 | S-ROM | 87-3435 | 873435 | 2015-09-24 |
| 10603295218470 | S-ROM | 87-3556 | 873556 | 2015-09-24 |
| 10603295218487 | S-ROM | 87-3557 | 873557 | 2015-09-24 |
| 10603295218951 | S-ROM | 87-5987 | 875987 | 2015-09-24 |
| 10603295519935 | VELYS | 4515-70-226 | 451570226 | 2021-05-26 |
| 10603295519430 | VELYS | 4515-70-102 | 451570102 | 2021-05-13 |
| 10603295519492 | VELYS | 4515-70-101 | 451570101 | 2021-05-13 |
| 10603295519515 | VELYS | 4515-70-100 | 451570100 | 2021-05-13 |
| 10603295519379 | VELYS | 4515-70-107 | 451570107 | 2021-05-07 |
| 10603295519461 | VELYS | 4515-70-105 | 451570105 | 2021-05-07 |
| 10603295519478 | VELYS | 4515-70-106 | 451570106 | 2021-05-07 |
| 10603295519485 | VELYS | 4515-70-109 | 451570109 | 2021-05-07 |
| 10603295170655 | S-ROM | 52-1503 | 521503 | 2015-09-24 |
| 10603295170662 | S-ROM | 52-1504 | 521504 | 2015-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10603295384816 | TRUMATCH | DEPUY (IRELAND) | NJL | 2018-09-24 |
| 10603295041863 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041870 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041887 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041894 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041917 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041931 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041948 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041962 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041979 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041986 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295041993 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042006 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042013 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042044 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042051 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042082 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042105 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042112 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295042129 | ATTUNE | DEPUY (IRELAND) | NJL | 2018-07-03 |
| 10603295419563 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295419570 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295419587 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295419594 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295419600 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295419617 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295436461 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295436492 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295436508 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |
| 10603295436515 | ATTUNE | DEPUY (IRELAND) | NJL | 2016-12-05 |