NA
- Primary DI
- 10603295025924
- Brand
- NA
- Company
- DEPUY (IRELAND)
- Model
- 1294-35-110
- Catalog number
- 129435110
- Device description
- TIBIAL TRAY ROTATING PLATFORM M.B.T. REVISION SIZE 1 CEMENTED
- Published
- 2015-03-24
- 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 | 074 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10603295025924 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10603295025924 | 10603295025924 |
GMDN Terms#
| Term | Definition |
|---|---|
| Uncoated knee tibia prosthesis, metallic | An implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with 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 |
|---|---|---|---|---|
| 10603295033141 | S-ROM | 1365-16-500 | 136516500 | 2015-09-24 |
| 10603295033158 | S-ROM | 1365-17-500 | 136517500 | 2015-09-24 |
| 10603295033165 | S-ROM | 1365-18-500 | 136518500 | 2015-09-24 |
| 10603295033738 | S-ROM | 1365-41-500 | 136541500 | 2015-09-24 |
| 10603295033752 | S-ROM | 1365-42-500 | 136542500 | 2015-09-24 |
| 10603295033776 | S-ROM | 1365-43-500 | 136543500 | 2015-09-24 |
| 10603295033790 | S-ROM | 1365-44-500 | 136544500 | 2015-09-24 |
| 10603295033851 | S-ROM | 1365-45-500 | 136545500 | 2015-09-24 |
| 10603295033875 | S-ROM | 1365-47-500 | 136547500 | 2015-09-24 |
| 10603295034056 | S-ROM | 1365-61-500 | 136561500 | 2015-09-24 |
| 10603295034094 | S-ROM | 1365-62-500 | 136562500 | 2015-09-24 |
| 10603295034131 | S-ROM | 1365-63-500 | 136563500 | 2015-09-24 |
| 10603295034179 | S-ROM | 1365-64-500 | 136564500 | 2015-09-24 |
| 10603295034216 | S-ROM | 1365-65-500 | 136565500 | 2015-09-24 |
| 10603295034230 | S-ROM | 1365-66-500 | 136566500 | 2015-09-24 |
| 10603295170778 | S-ROM | 52-2022 | 522022 | 2015-09-24 |
| 10603295079941 | AML EXCEL | 2001-42-000 | 200142000 | 2018-09-24 |
| 10603295080008 | AML EXCEL | 2001-47-000 | 200147000 | 2018-09-24 |
| 10603295080015 | AML EXCEL | 2001-48-000 | 200148000 | 2018-09-24 |
| 10603295080022 | AML EXCEL | 2001-49-000 | 200149000 | 2018-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10603295520634 | ATTUNE | DEPUY (IRELAND) | NJL | 2023-06-30 |
| 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 |