510(k) K250216
- Device
- OsteoProbe (OP-100)
- Applicant
- Active Life Scientific, Inc.
- 510(k) number
- K250216
- Product code
- QGQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-11
- Date received
- 2025-01-24
- Regulation
- 888.1600
- Classification name
- Bone Indentation Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Alexander Proctor
- Address
- 228 W. Carrillo St., Suite A Santa Barbara CA US 93101 93101
FDA Registration Numbers#
- 2027062
- 3014894280