Biotech Traumatological Implant Systems for Osteosynthesis
Basic Information
- Primary DI
- D-4049852TR1FFXY
- Basic UDI-DI Code
- B-4049852TR1FFXY
- Reference
- 4049852TR1FF
- Device Types
-
Single use Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Biotech GmbH
Additional Description
The Biotech Traumatological Implant Systems for Osteosynthesis is a non-active, osteosynthesis type of surgical implant system, including various types of implants: screws, plates, pins, wires, staples, intramedullary nails and implants for femoral neck screw fixation, dynamic screw fixation, and external fixation. The implants provide an alternative to “traditional” methods of bone fracture fixation, because their use does not require sanding of intact bone tissue and deliver a safe and stable structural rigidity for bones and soft tissues throughout the healing process. The implants of Biotech Traumatological Implant Systems for Osteosynthesis are made of titanium alloy (TIAI6V4) or High Nitrogen Stainless Steel.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P091299 | OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER |
| P09120699 | BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER |
| P09120606 | OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS |
| P09120605 | INTERFERENCE SCREWS |
| P09120604 | OSTEOSYNTHESIS NAIL-SCREW SYSTEMS |
| P09120603 | CANNULATED SCREWS |
| P09120602 | CANCELLOUS SCREWS |
| P09120601 | CORTICAL SCREWS |
| P09120599 | BONE FIXATION PLATES - OTHER |
| P09120504 | OSTEOSYNTHESIS BLADE-PLATE SYSTEMS |
| P09120503 | OSTEOSYNTHESIS SCREW-PLATE SYSTEMS |
| P09120502 | OSTEOSYNTHESIS NEUTRALISATION AND SUPPORT PLATES |
| P09120501 | OSTEOSYNTHESIS COMPRESSION PLATES |
| P09120499 | EXTERNAL BONE FIXATION SYSTEMS - OTHER |
| P09120403 | OSTEOSYNTHESIS DISTRACTORS |
| P09120402 | SCREWS |
| P0912040102 | AXIAL BONE FIXATION SYSTEMS |
| P0912040101 | RADIAL BONE FIXATION SYSTEMS |
| P09120399 | BONE FIXATION WIRES - OTHER |
| P09120302 | CERCLAGE DEVICES, WIRES AND BINDERS |
| P09120301 | KIRSCHNER BONE WIRES |
| P09120299 | OSTEOSYNTHESIS NAILS - OTHER |
| P09120202 | INTRAMEDULLARY NAILS IN COMPLEX SYSTEMS |
| P09120201 | INTRAMEDULLARY NAILS |
| P09120102 | ANCHORS, TENDON AND LIGAMENT SYNTHESIS |
| P09120101 | OSTEOSYNTHESIS STAPLES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | No. 5-903-200-2123 | NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).