Altiva Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Altiva Corp.” (first 2005, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Altiva Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070891 | ALTIVA CLASSIC ACP SYSTEM | KWQ | 2007-06-11 | 73 |
| K061482 | ALTES BUTTRESS PLATING SYSTEM | KWQ | 2006-07-26 | 57 |
| K053070 | CONTOUR II SPINAL SYSTEM | MNH | 2006-02-13 | 104 |
| K051044 | ARCTEC SEMIRIGID PLATING SYSTEM | MNH | 2005-10-07 | 165 |
| K051216 | HYDRALOK SYSTEM | MNH | 2005-07-19 | 68 |
Recalls
openFDA lists no recalls under a recalling firm named Altiva 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 Altiva Corp.?
FDA lists 5 510(k) clearances under the applicant name “Altiva Corp.” (first 2005, latest 2007), 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 Altiva Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Altiva Corp. is 73 days.
Which FDA product codes appear under Altiva Corp.?
The most frequent FDA product codes under this applicant name are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 5 Altiva Corp. clearances with predicates and recalls
- Run predicate analysis for product code MNH, Altiva 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.