Osteoboost Belt
FDA 510(k) clearance DEN230015 · decided 2024-01-12
Clearance details
- K-number
- DEN230015
- Device name
- Osteoboost Belt
- Applicant
- Bone Health Technologies, Inc.
- Decision
- Unknown
- Date received
- 2023-02-17
- Decision date
- 2024-01-12
- Days to decision
- 329 days
- Clearance type
- Direct
- Product code
- QZO
- Device class
- 2
- Regulation number
- 888.5895
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bone Health Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.