Data / Medical devices / Germany / Biocomposites GmbH (former ARTOSS GmbH)
Biocomposites GmbH (former ARTOSS GmbH): FDA-registered device maker in Rostock Mecklenburg-Western Pomerania, Germany, 2 510(k) clearances
Biocomposites GmbH (former ARTOSS GmbH) is registered with the FDA (registration 3011483489) in Rostock Mecklenburg-Western Pomerania, Germany. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 7, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011483489
- Address
- Fischerweg 421, Rostock Mecklenburg-Western Pomerania, Germany, 18069
- Owner or operator
- Biocomposites GmbH (former ARTOSS GmbH) (10048987)
- Roles
- Manufacturer
- First device listed
- June 6, 2019
- Registered through
- 2027
- Brand names listed
- NanoBone QD, NanoBone SBX Putty
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | 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 |
|---|---|---|---|---|---|---|
| April 7, 2025 | K250521 | NanoBone® SBX Putty ; NanoBone® QD | MQV | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| April 23, 2019 | K190110 | NanoBone SBX PUTTY, NanoBone QD | MQV | Substantially Equivalent | Artoss GmbH | accessdata.fda.gov |
Compare with other makers
Updated April 7, 2025. 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.