Theragen, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Theragen, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LOF | Stimulator, Bone Growth, Non-Invasive | 1 | 0 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190030 | PMA | ActaStim-S Spine Fusion Stimulator | 2020-12-09 |
Recalls
openFDA lists no recalls under a recalling firm named Theragen, 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.
Device clinical trials
An industry sponsor named Theragen, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01548040: Controlled Study of Kneehab XP for Patients Undergoing Total Knee Replacement (Completed, started 2012-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Theragen, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Theragen, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Theragen, Inc.?
The most frequent FDA product codes under this applicant name are LOF (Stimulator, Bone Growth, Non-Invasive, 1).
Next steps
- See all 0 Theragen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LOF, Theragen, 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.