Acromed Corp.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Acromed Corp.” (first 1984, latest 1998), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 | 14 | 14 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 14 | 14 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 11 | 11 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (40)
Most recent Acromed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980485 | ISOLA SPINAL SYSTEM | MNI | 1998-10-21 | 254 |
| K981714 | TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM | MNH | 1998-06-30 | 46 |
| K981113 | PEDIATRIC PRC | MNH | 1998-05-29 | 63 |
| K981274 | ACROMED TIMX PLATE BASED LOW BACK SYSTEM | MNH | 1998-04-29 | 21 |
| K980228 | UNIVERSITY PLATE ANTERIOR SYSTEM | KWQ | 1998-04-14 | 82 |
| K974757 | KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS | KWQ | 1998-03-05 | 76 |
| K972718 | M-2 ANTERIOR PLATE SYSTEM | KWQ | 1997-10-01 | 72 |
| K971248 | KANEDA SR ANTERIOR SPINAL SYSTEM | KWQ | 1997-06-11 | 69 |
| K970955 | ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM | KWQ | 1997-06-11 | 86 |
| K970950 | EASY ROD | MNH | 1997-06-03 | 81 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acromed 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 Acromed Corp.?
FDA lists 41 510(k) clearances under the applicant name “Acromed Corp.” (first 1984, latest 1998), across 5 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 Acromed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acromed Corp. is 88 days.
Which FDA product codes appear under Acromed Corp.?
The most frequent FDA product codes under this applicant name are KWP (Appliance, Fixation, Spinal Interlaminal, 14); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 14); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 11).
Next steps
- See all 41 Acromed Corp. clearances with predicates and recalls
- Run predicate analysis for product code KWP, Acromed 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.