Cleared Traditional

K192629 - Spinalytics (FDA 510(k) Clearance)

K192629 · Optima Health Solutions International Corp. · Neurology device
Dec 2019
Decision
89d
Days
-
Risk

K192629 is an FDA 510(k) clearance for the Spinalytics. This device is classified as a Manipulator, Plunger-like Joint.

Submitted by Optima Health Solutions International Corp. (Vancouver, CA). The FDA issued a Cleared decision on December 21, 2019, 89 days after receiving the submission on September 23, 2019.

This device falls under the Neurology FDA review panel.

Submission Details

510(k) Number K192629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2019
Decision Date December 21, 2019
Days to Decision 89 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LXM - Manipulator, Plunger-like Joint
Device Class -