Data / Medical devices / Germany / Riwospine GMBH
Riwospine GMBH: FDA-registered device maker in Knittlingen Baden-Wurttemberg, Germany, 4 510(k) clearances
Riwospine GMBH is registered with the FDA (registration 3017406274) in Knittlingen Baden-Wurttemberg, Germany. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 20, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017406274
- Address
- Pforzheimer Strasse 32, Knittlingen Baden-Wurttemberg, Germany, 75438
- Owner or operator
- RIWOspine GmbH (10093852)
- Roles
- Exporter to the US
- First device listed
- July 22, 2025
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Exporter to the US | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Exporter to the US | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Exporter to the US | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Exporter to the US | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Exporter to the US | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 20, 2023 | K230700 | RIWOtrack Navigation System | OLO | Substantially Equivalent | Fiagon GmbH | accessdata.fda.gov |
| April 5, 2017 | K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM | GEI | Substantially Equivalent | Richard Wolf Medical Instruments Corporation | accessdata.fda.gov |
| September 10, 2010 | K100736 | KIRSCHNER AND GUIDE WIRES | HTY | Substantially Equivalent | Smt Schilling Metalltechnik GmbH | accessdata.fda.gov |
| March 30, 2000 | K000046 | KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) | HRX | Substantially Equivalent | Richard Wolf Medical Instruments Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Pin, Fixation, Threaded
- All makers of Pin, Fixation, Smooth
Updated November 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.