Altius
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 08902618005441
- Basic UDI-DI Code
- B-08902618005441
- Reference
- BPP2
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- TTK Healthcare Limited (Ortho Division)
Additional Description
All poly patellar component is constructed from UHMWPE that complies with the material Standard ISO 5834-2, Type-2 / ASTM F648, fabricated form Type-2. The non-rotating bearing has a similar surface with the lateral surface being a concave; however, the medial surface is a single, concave are providing reasonable contact throughout patellar rotation. It is available in six sizes. The Knee All Poly Patellar Component is supplied in sterile condition after being sterilised using Ethylene Oxide sterilization process.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P0909070201 | PATELLAR COMPONENTS, MONOBLOCK |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 11251-2017-CE-IND-NA-PS | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).