OsteoProbe (OP-100)— 510(k) K250216

Name: FDA 510(k) clearance K250216
Creator: U.S. Food and Drug Administration
Published: 2025-09-11

Substantially Equivalent

Active Life Scientific, Inc.

FDA 510(k) clearance K250216 for OsteoProbe (OP-100), Substantially Equivalent on 2025-09-11. Applicant: Active Life Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Active Life Scientific, Inc.
Product code: Code QGQ
Device class: Class 2
Regulation: 21 CFR 888.1600
Advisory panel: Orthopedic
Date received: 2025-01-24
Decision date: 2025-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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