Ossdsign AB: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ossdsign AB” (first 2014, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 172 days. Since 2017 the median was 123 days, against 101 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 238 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 276 |
| 2018 | 1 | 123 |
| 2019 | 1 | 220 |
| 2020 | 0 | — |
| 2021 | 1 | 59 |
| 2022 | 0 | — |
| 2023 | 1 | 44 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ossdsign AB took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXR | Cover, Burr Hole | 2 | 2 |
| PJN | Filler, Bone Void, Non-Alterable Compound For Cranioplasty | 2 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Neurology (5)
- Orthopedic (1)
Most recent Ossdsign AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232315 | Catalyst Bone Void Filler | MQV | 2023-09-15 | 44 |
| K212414 | OSSDSIGN Cranial PSI | PJN | 2021-10-01 | 59 |
| 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 | 2019-10-10 | 220 |
| K181539 | OSSDSIGN Cranioplug | GXR | 2018-10-12 | 123 |
| K161090 | Cranial PSI | GXN | 2017-01-19 | 276 |
| K140309 | CRANIOPLUG | GXR | 2014-10-03 | 238 |
Recalls
openFDA lists no recalls under a recalling firm named Ossdsign AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ossdsign AB?
FDA lists 6 510(k) clearances under the applicant name “Ossdsign AB” (first 2014, latest 2023), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ossdsign AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ossdsign AB is 172 days. Since 2017: 123 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ossdsign AB?
The most frequent FDA product codes under this applicant name are GXR (Cover, Burr Hole, 2); PJN (Filler, Bone Void, Non-Alterable Compound For Cranioplasty, 2); GXN (Plate, Cranioplasty, Preformed, Non-Alterable, 1).
Next steps
- See all 6 Ossdsign AB clearances with predicates and recalls
- Run predicate analysis for product code GXR, Ossdsign AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.