Cohort Medical Products Group, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cohort Medical Products Group, Inc.” (first 1994, latest 1997), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| HXB | Probe | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Cohort Medical Products Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964975 | COHORT DISCECTOMY SYSTEMS (CDS) | HRX | 1997-02-24 | 74 |
| K950011 | COHORT(TM) ANTERIOR PLATE SYSTEM (APS) | KWQ | 1995-11-06 | 307 |
| K943804 | BONE SCREW | HWC | 1994-12-08 | 126 |
| K943472 | COHORT AVB RETRACTOR SYSTEM | HXB | 1994-10-20 | 93 |
| K943474 | CANNULATED BONE SCREW | HWC | 1994-10-14 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Cohort Medical Products Group, 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 Cohort Medical Products Group, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cohort Medical Products Group, Inc.” (first 1994, latest 1997), across 4 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 Cohort Medical Products Group, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cohort Medical Products Group, Inc. is 93 days.
Which FDA product codes appear under Cohort Medical Products Group, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 2); HRX (Arthroscope, 1); HXB (Probe, 1).
Next steps
- See all 5 Cohort Medical Products Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Cohort Medical Products Group, 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, 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.