Ossdsign
Uppsala, SE
OSSDSIGN appears in FDA device records in Uppsala, SE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Ossdsign between 2014 and 2023. The busiest year on record is 2014, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232315 | Catalyst Bone Void Filler | MQV | Substantially Equivalent | |
| K212414 | OSSDSIGN Cranial PSI | PJN | Substantially Equivalent | |
| K190523 | Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial | PJN | Substantially Equivalent | |
| K181539 | OSSDSIGN Cranioplug | GXR | Substantially Equivalent | |
| K161090 | Cranial PSI | GXN | Substantially Equivalent | |
| K140309 | CRANIOPLUG | GXR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013282271 | 3013282271 | OSSDSIGN | Ulls vag 29C, Uppsala SE 756 51 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain