OsteoBridge IDSF System
FDA 510(k)Class II (US FDA 510(k))
by Merete GmbH
Identifiers
- 510(k) Number
- K181026 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OsteoBridge IDSF System is an orthopedic device used for spinal fusion procedures. It is designed to provide stabilization and support in spinal surgeries.
The system is supplied by Merete GmbH and has FDA 510K clearance. It is manufactured in Berlin, Germany, and is intended for use in orthopedic applications.
Frequently asked questions
What is the OsteoBridge IDSF System used for?
The OsteoBridge IDSF System is an orthopedic device designed specifically for spinal fusion procedures. It provides stabilization and support during spinal surgeries to help promote proper healing and alignment of the spine.
How is the OsteoBridge IDSF System supplied?
The system is supplied by Merete GmbH, a manufacturer based in Berlin, Germany. It is intended for use in orthopedic applications and is designed to meet the specific needs of spinal fusion procedures.
What is the regulatory status of the OsteoBridge IDSF System?
The OsteoBridge IDSF System has FDA 510K clearance with a decision code of SESE (Substantially Equivalent) and was reviewed by the Orthopedic advisory committee. It received clearance on October 17, 2018.
What are the specifications of the OsteoBridge IDSF System?
The OsteoBridge IDSF System is classified under product code HSB and is considered a special clearance type. It is manufactured at Alt-Lankwitz 102, Berlin, 12247, Germany, and is designed for orthopedic applications in spinal fusion procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181026 | Class II | Active |
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Manufacturer
- Manufacturer
- Merete GmbH
Sources (1)
- FDA 510(k) K181026 24 fields · synced Sep 21, 2026