Cleared Traditional

K232023 - Momentum Spine (FDA 510(k) Clearance)

K232023 · Momentum Health, Inc. · Physical Medicine device
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Oct 2023
Decision
89d
Days
-
Risk

K232023 is an FDA 510(k) clearance for the Momentum Spine. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Momentum Health, Inc. (Montreal, CA). The FDA issued a Cleared decision on October 4, 2023 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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 Momentum Health, Inc. devices

Submission Details

510(k) Number K232023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2023
Decision Date October 04, 2023
Days to Decision 89 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDK Device, Sensing, Optical Contour
Device Class -