Djo Global: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Djo Global” (first 2014, latest 2014), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 48 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 Enovis (DJO), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 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 |
|---|---|---|---|
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | 1 | 0 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 1 | 1 |
Review panels
- Orthopedic (2)
Most recent Djo Global 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K141006 | RSP HUMERAL SOCKET INSERT | PHX | 2014-06-05 | 48 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050050 | PMA | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) | 2009-05-27 |
Recalls
openFDA lists no recalls under a recalling firm named Djo Global.
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 Djo Global?
FDA lists 1 510(k) clearance under the applicant name “Djo Global” (first 2014, latest 2014), plus 1 PMA decision, 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 Djo Global?
The median time from FDA receipt to decision across 510(k)s cleared under the name Djo Global is 48 days.
Which FDA product codes appear under Djo Global?
The most frequent FDA product codes under this applicant name are NTG (Prosthesis, Ankle, Uncemented, Non-Constrained, 1); PHX (Shoulder Prosthesis, Reverse Configuration, 1).
Next steps
- See all 1 Djo Global clearances with predicates and recalls
- Run predicate analysis for product code NTG, Djo Global'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.