Data / Medical devices / Sweden / Ossdsign
Ossdsign: FDA-registered device maker in Uppsala, Sweden, 2 510(k) clearances
Ossdsign is registered with the FDA (registration 3013282271) in Uppsala, Sweden. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013282271
- Address
- Ulls vag 29C, Uppsala, Sweden, SE 756 51
- Owner or operator
- OssDsign (10054133)
- Roles
- Specification developer
- First device listed
- April 27, 2021
- Registered through
- 2026
- Brand names listed
- Catalyst Bone Void Filler, OssDsign Catalyst, Osteo3 ZP Putty
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 15, 2023 | K232315 | Catalyst Bone Void Filler | MQV | Substantially Equivalent | Ossdsign AB | accessdata.fda.gov |
| June 9, 2020 | K193075 | Osteo3 ZP Putty | MQV | Substantially Equivalent | Sirakoss , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 15, 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.