Momentum Spine

510(k)K232023RadiologyLDK

Momentum Health Inc. is listed for Momentum Spine (K232023). The FDA list gives October 4, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LDK. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232023

Official FDA database record

Date of final decision: October 4, 2023
Company on the FDA list: Momentum Health Inc.
Lead panel: Radiology
Primary product code: LDK
openFDA device name for the code: Device, Sensing, Optical Contour
Device class: U
Regulation number: Not returned
openFDA decision description: Substantially Equivalent
openFDA decision code: SESE
Statement or summary label: Summary