Cleared Traditional

Spinalytics (K192629) - FDA 510(k) Clearance

K192629 · Optima Health Solutions International Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2019
Decision
89d
Days
-
Risk

K192629 is an FDA 510(k) clearance for the Spinalytics. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Optima Health Solutions International Corp. (Vancouver, CA). The FDA issued a Cleared decision on December 21, 2019 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Optima Health Solutions International Corp. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 148d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Emergo Global Consulting, LLC
Diane Sudduth

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.