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Sign in to claim this brandWhat Bioretec Oy makes
Bioretec Oy manufactures bioabsorbable orthopaedic fixation devices, including screws, pins, and wires designed for internal bone stabilization. Their product line also covers reusable surgical instruments such as fluted drill bits, impactors, screwdrivers, taps, and drill guides, primarily for orthopaedic procedures. The company produces disposable pin applicators for precise bone fixation applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with most products listed in the FDA’s Unique Device Identifier (UDI) system. These devices are intended for use in the United States, adhering to applicable regulatory standards for medical device authorisation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bioretec Oy manufacture?
Bioretec Oy specializes in orthopaedic fixation devices, including bioabsorbable screws, pins, and wires for internal bone stabilization. Their product line also includes reusable surgical instruments like fluted drill bits, impactors, screwdrivers, taps, and drill guides, as well as disposable pin applicators. These devices are designed for orthopaedic procedures to aid in bone healing and stabilization.
Where is Bioretec Oy based, and what markets do they serve?
Bioretec Oy is based in the United States. Their devices are intended for use in the US market, where they must comply with applicable regulatory standards for medical device authorisation. The company’s products are tailored for orthopaedic applications, focusing on bone fixation and surgical precision.
Which regulatory registries list Bioretec Oy’s devices?
Bioretec Oy’s devices are listed in the FDA’s Unique Device Identifier (UDI) system. This registry ensures traceability and compliance tracking for medical devices authorised in the United States. The UDI system helps healthcare providers and regulators identify and monitor specific devices throughout their lifecycle.
How are Bioretec Oy’s devices classified under FDA regulations?
Bioretec Oy’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bioretec.com
- —
- —
- [email protected]
- Phone
- +358207789500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 368715301
Catalogue (437)
Page 5 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ActivaScrew™ | B-ALC-4025 | FDA UDI | Class II | Active |
| ActivaScrew™ | B-AL-4560 | FDA UDI | Class II | Active |
| Activa Instrument | B-IS-9033 | FDA UDI | Class I | Active |
| Activa Instrument | B-ISC-1251 | FDA UDI | Class I | Active |
| RFS™ Screw | RFS-C4050L | FDA UDI | Class II | Unknown |
| RFS™ Screw | RFS-S3532 | FDA UDI | Class II | Unknown |
| ActivaScrew™ | B-ASC-4570 | FDA UDI | Class II | Active |
| RFS™ Screw | RFS-S3524 | FDA UDI | Class II | Unknown |
| Activa Instrument | B-IP-2003 | FDA UDI | Class I | Active |
| RFS Disposable Pin Applicator | RFS-PA27 | FDA UDI | Class II | Unknown |
| RFS™ Screw | RFS-C3545L | FDA UDI | Class II | Unknown |
| TorqLoc Interference | 10-1009-0515 | FDA UDI | Class II | Unknown |
| TorqLoc Instrument | OP-II-0815B | FDA UDI | Class I | Unknown |
| Activa Instrument | B-ISC-1602 | FDA UDI | Class I | Active |
| Activa Instrument | B-IS-9020 | FDA UDI | Class I | Active |
| Activa Instrument | B-IS-3505 | FDA UDI | Class I | Active |
| RFS™ Screw | RFS-C4545L | FDA UDI | Class II | Unknown |
| RFS™ Screw | RFS-C3524 | FDA UDI | Class II | Unknown |
| RFS™ Screw | RFS-C3528 | FDA UDI | Class II | Unknown |
| Activa Instrument | B-IS-9021 | FDA UDI | Class I | Active |
| Activa Instrument | B-IP-2001 | FDA UDI | Class I | Active |
| RFS Instrument | RFS-TA27 | FDA UDI | Class I | Unknown |
| RFS Instrument | RFS-CKW160T | FDA UDI | Class I | Unknown |
| RFS™ Screw | RFS-S3536 | FDA UDI | Class II | Unknown |
| TorqLoc Interference | 10-1009-0720 | FDA UDI | Class II | Unknown |
| ActivaScrew™ | B-ASC-3528 | FDA UDI | Class II | Active |
| ActivaScrew™ | B-ALC-4050 | FDA UDI | Class II | Active |
| Activa Instrument | B-IP-2703 | FDA UDI | Class I | Active |
| Activa Instrument | B-IP-2700 | FDA UDI | Class I | Active |
| ActivaScrew™ Interference | B-AI-0828 | FDA UDI | Class II | Active |
| Activa Instrument | B-IS-4504 | FDA UDI | Class I | Active |
| ActivaPin™ | B-AP-2060 | FDA UDI | Class II | Active |
| Activa Instrument | B-II-9031 | FDA UDI | Class I | Active |
| RFS Instrument | RFS-DR32 | FDA UDI | Class I | Unknown |
| RFS™ Screw | RFS-C4590 | FDA UDI | Class II | Unknown |
| Activa Instrument | B-IS-4501 | FDA UDI | Class I | Active |
| RFS™ Screw | RFS-C4080 | FDA UDI | Class II | Unknown |
| Activa Instrument | B-II-9032 | FDA UDI | Class I | Active |
| Activa Instrument | B-IP-1500 | FDA UDI | Class I | Active |
| ActivaScrew™ | B-ALC-4565 | FDA UDI | Class II | Active |
| Activa Instrument | B-ISC-3502 | FDA UDI | Class I | Active |
| ActivaScrew™ Interference | B-AI-0415 | FDA UDI | Class II | Active |
| Activa Instrument | B-IS-4500 | FDA UDI | Class I | Active |
| RFS™ Screw | RFS-C4060L | FDA UDI | Class II | Unknown |
| Activa Instrument | B-ISC-3501 | FDA UDI | Class I | Active |
| ActivaNail™ | B-ANCO-2015 | FDA UDI | Class II | Active |
| Activa Instrument | B-ISS-1000 | FDA UDI | Class I | Active |
| ActivaScrew™ Interference | B-AI-0928 | FDA UDI | Class II | Active |
| RFS™ Screw | RFS-S3530L | FDA UDI | Class II | Unknown |
| TorqLoc Interference | 10-1009-0933 | FDA UDI | Class II | Unknown |
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