Ostex Intl., Inc.: FDA clearances and approvals
Ostex Intl., Inc. has 5 FDA 510(k) clearances (first 1995, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time: 115 days.
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 |
|---|---|---|---|
| JMM | Column Chromatography & Color Development, Hydroxyproline | 5 | 5 |
Review panels
Most recent Ostex Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011052 | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | JMM | 2001-07-30 | 115 |
| K983457 | OSTEOMARK NTX SERUM EIA | JMM | 1999-02-02 | 125 |
| K980518 | OSTEOMARK | JMM | 1998-03-06 | 49 |
| K961562 | OSTEOMARK | JMM | 1996-07-11 | 80 |
| K945946 | OSTEOMARK(R) | JMM | 1995-05-08 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Ostex Intl., Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ostex Intl., Inc. have?
Ostex Intl., Inc. has 5 FDA 510(k) clearances (first 1995, latest 2001), across 1 product code in 1 review panel.
How long does FDA take to clear Ostex Intl., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ostex Intl., Inc.'s cleared 510(k)s is 115 days.
What devices does Ostex Intl., Inc. make?
Its most frequent FDA product codes are JMM (Column Chromatography & Color Development, Hydroxyproline, 5).
Has Ostex Intl., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ostex Intl., Inc. Related entities may recall under other names.
Next steps
- See all 5 Ostex Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JMM, Ostex Intl., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.