Next Orthosurgical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Next Orthosurgical” (first 2013, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 106 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 |
|---|---|---|
| 2013 | 1 | 130 |
| 2014 | 1 | 99 |
| 2015 | 0 | — |
| 2016 | 2 | 85 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 275 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Next Orthosurgical took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Next Orthosurgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242509 | HAnano InterFuse(R) Modular Interbody | MAX | 2024-09-19 | 28 |
| K190981 | NEX-D2 Posterior Fixation System | NKB | 2020-01-15 | 275 |
| K161608 | InterForm Cervical Interbody Cage System | ODP | 2016-09-30 | 112 |
| K161499 | VertiForm Posterior Fixation System | NKB | 2016-07-29 | 58 |
| K141291 | VERTIFORM POSTERIOR FIXATION SYSTEM | NKB | 2014-08-26 | 99 |
| K131082 | INTERFORM INTERBODY CAGE SYSTEM | MAX | 2013-08-26 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Next Orthosurgical.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Next Science, LLC (6 510(k)s)
- Next Mobility, LLC (2 510(k)s)
- Next Wave, Inc. (2 510(k)s)
- Next Millennium Software Solutions, Inc. (1 510(k)s)
- Next Sight Srl (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Next Orthosurgical?
FDA lists 6 510(k) clearances under the applicant name “Next Orthosurgical” (first 2013, latest 2024), 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 Next Orthosurgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Next Orthosurgical is 106 days.
Which FDA product codes appear under Next Orthosurgical?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 1).
Next steps
- See all 6 Next Orthosurgical clearances with predicates and recalls
- Run predicate analysis for product code NKB, Next Orthosurgical'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.