Data / Medical devices / Germany / Joline GMBH & Co. KG
Joline GMBH & Co. KG: FDA-registered device maker in HECHINGEN Baden-Wurttemberg, Germany, 1 510(k) clearance
Joline GMBH & Co. KG is registered with the FDA (registration 3004734264) in HECHINGEN Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004734264
- Address
- Neue Rottenburger Strasse 50, HECHINGEN Baden-Wurttemberg, Germany, D72379
- Owner or operator
- JOLINE GMBH & CO. KG (9106819)
- Roles
- Manufacturer
- First device listed
- July 14, 2020
- Registered through
- 2026
- Brand names listed
- Kyphoplasty System Allevo, Mixer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Bone, Vertebroplasty | NDN | 2 | Manufacturer | accessdata.fda.gov |
| Mixer, Cement, For Clinical Use | JDZ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| May 27, 2020 | K192449 | Joline Kyphoplasty System Allevo | NDN | Substantially Equivalent | Joline GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Arthroscope
- All makers of Cement, Bone, Vertebroplasty
- All makers of Mixer, Cement, For Clinical Use
Updated May 27, 2020. 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.