SIGMA
- Primary DI
- 10603295241997
- Brand
- SIGMA
- Company
- DEPUY ORTHOPAEDICS, INC.
- Model
- 96-2314
- Catalog number
- 962314
- Device description
- SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE 1.5 17.5mm GVF
- Published
- 2015-03-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product 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 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10603295241997 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10603295241997 | 10603295241997 |
GMDN Terms
| Term | Definition |
|---|
| Tibial insert | An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer. |
Regulatory Flags
- DUNS number
- 080506581
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10603295503309 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503316 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503323 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503330 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503347 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503354 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503361 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
| 10603295503378 | ATTUNE | DEPUY (IRELAND) | NJL | 2026-01-13 |
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