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510(k) DEN210013

OsteoProbe by Active Life Scientific, Inc. — Product Code QGQ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: August 19, 2021
Date Received: March 30, 2021
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bone Indentation Device
Device Class: Class II
Regulation Number: 888.1600
Review Panel: OR
Submission Type

A bone indentation device is a device that measures resistance to indentation in bone.