Rotation Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Rotation Medical, Inc.” (first 2011, latest 2014), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Smith+Nephew, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 86 |
| 2014 | 1 | 48 |
| 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | 2 | 2 |
| GDW | Staple, Implantable | 1 | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 | 1 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 1 | 1 |
Review panels
Most recent Rotation Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | OWY | 2014-03-26 | 48 |
| K131635 | ROTATION MEDICAL BONE STAPLE (RMB STAPLE) | MBI | 2013-08-29 | 86 |
| K131637 | ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE) | GDW | 2013-07-12 | 38 |
| K122048 | COLLAGEN TENDON SHEET-D | FTM | 2013-01-08 | 180 |
| K112423 | COLLAGEN TENDON SHEET | FTM | 2011-12-22 | 121 |
Recalls
openFDA lists no recalls under a recalling firm named Rotation Medical, 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 Rotation Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Rotation Medical, Inc.” (first 2011, latest 2014), 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 Rotation Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rotation Medical, Inc. is 86 days.
Which FDA product codes appear under Rotation Medical, Inc.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 2); GDW (Staple, Implantable, 1); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 1).
Next steps
- See all 5 Rotation Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Rotation Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.