Arcan Orthopaedic Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Arcan Orthopaedic Corp.” (first 1994, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 | 4 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Arcan Orthopaedic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971457 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED | KWP | 1997-07-16 | 110 |
| K955927 | BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) | KWP | 1996-03-13 | 82 |
| K953416 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | MNH | 1995-10-03 | 85 |
| K945435 | BRYAN POSTERIOR SPINAL FIXATOR (BPSF) | KWP | 1995-05-31 | 236 |
| K914548 | BRYAN SPINAL FIXATER (BSF) | KWP | 1994-03-28 | 899 |
Recalls
openFDA lists no recalls under a recalling firm named Arcan Orthopaedic Corp..
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 Arcan Orthopaedic Corp.?
FDA lists 5 510(k) clearances under the applicant name “Arcan Orthopaedic Corp.” (first 1994, latest 1997), across 2 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 Arcan Orthopaedic Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arcan Orthopaedic Corp. is 110 days.
Which FDA product codes appear under Arcan Orthopaedic Corp.?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 4); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 5 Arcan Orthopaedic Corp. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Arcan Orthopaedic Corp.'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.