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510(k) K232023

Momentum Spine by Momentum Health, Inc. — Product Code LDK

K232023 is an FDA 510(k) premarket notification submitted by Momentum Health, Inc. for the device "Momentum Spine". The FDA issued a decision of Substantially Equivalent on October 4, 2023. The device falls under product code LDK (Device, Sensing, Optical Contour), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2023
Date Received
July 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Sensing, Optical Contour
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances for product code LDK

  • K230463 — NSite Scoliosis Assessment App (November 15, 2023)
  • K183485 — CryoVizion System (August 28, 2019)
  • K923792 — QUANTEC SPINAL MEASUEMENT SYSTEM (April 20, 1994)
  • K860225 — METRICOM (February 11, 1986)
  • K851133 — TERRAN BIOMECHANICAL ANALYSIS SYSTEM (June 19, 1985)
  • K844736 — ISIS (March 21, 1985)
  • K800591 — CONTOUROGRAPH M-500 (April 2, 1980)

FDA data resources