Data / Medical devices / Sweden / Bone Support AB
Bone Support AB: FDA-registered device maker in LUND Skane, Sweden, 3 510(k) clearances
Bone Support AB is registered with the FDA (registration 3005304945) in LUND Skane, Sweden. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005304945
- Address
- Scheelevagen 19, LUND Skane, Sweden, SE-22370
- Owner or operator
- BONE SUPPORT AB (9075333)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 28, 2019
- Registered through
- 2026
- Brand names listed
- CERAMENT BONE VOID FILLER, CERAMENT BEAD TRAY, CERAMENT G, CERAMENT BEAD TRAY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside | QRR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 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 |
|---|---|---|---|---|---|---|
| March 13, 2024 | K234008 | CERAMENT G | QRR | Substantially Equivalent | Bonesupport AB | accessdata.fda.gov |
| May 17, 2022 | DEN210044 | CERAMENT G | QRR | Unknown | Bonesupport AB | accessdata.fda.gov |
| October 16, 2020 | K201535 | Cerament Bone Void Filler | MQV | Substantially Equivalent | Bonesupport AB | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Updated March 13, 2024. 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.