Scandius Biomedical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Scandius Biomedical, Inc.” (first 2004, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | 2 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
Review panels
- Orthopedic (6)
Most recent Scandius Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063499 | MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | MBI | 2006-12-19 | 29 |
| K063497 | MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM | MAI | 2006-12-19 | 29 |
| K060522 | SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM | MAI | 2006-04-11 | 43 |
| K052810 | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | MBI | 2005-12-20 | 77 |
| K041961 | SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM | HWC | 2004-10-20 | 91 |
| K041749 | SCANDIUS ACL RECONSTRUCTION SYSTEM | HWC | 2004-09-08 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Scandius Biomedical, Inc..
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 Scandius Biomedical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Scandius Biomedical, Inc.” (first 2004, latest 2006), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Scandius Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Scandius Biomedical, Inc. is 57 days.
Which FDA product codes appear under Scandius Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 2); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 2); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2).
Next steps
- See all 6 Scandius Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Scandius Biomedical, Inc.'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.