Bone Health Technologies, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Bone Health Technologies, Inc.”, plus 1 De Novo 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 |
|---|---|---|---|
| QZO | Wearable Vibration Device For Orthopedic Use | 1 | 0 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230015 | De Novo | Wearable Vibration Device For Orthopedic Use | 2024-01-12 |
Recalls
openFDA lists no recalls under a recalling firm named Bone Health Technologies, 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 Bone Health Technologies, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05457036: Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile (Completed, started 2022-09-01)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bone Solutions, Inc. (9 510(k)s)
- Bone Index Finland , Ltd. (3 510(k)s)
- Bone Anchorage Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bone Health Technologies, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Bone Health Technologies, Inc.”, plus 1 De Novo 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 Bone Health Technologies, Inc.?
The most frequent FDA product codes under this applicant name are QZO (Wearable Vibration Device For Orthopedic Use, 1).
Next steps
- See all 0 Bone Health Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QZO, Bone Health Technologies, 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.