Radiology · 510(k) · 2023
Momentum Spine
Momentum Health Inc.. Cleared by FDA on 4 October 2023 under submission K232023, product code LDK (device, sensing, optical contour). What FDA's record says, in FDA's words.
Device record · K232023
- Device. Momentum SpineDEVICE
- Company. Momentum Health Inc. (CA)COMPANY
- Decision. 4 October 2023, 510(k), substantially equivalent (traditional review); received 7 July 2023DECISION
- Panel. RadiologyPANEL
- Product code. LDK, Device, Sensing, Optical ContourCODE
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians. The device is intended for use in patients 8 years and older.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1 report filed against devices carrying product code LDK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
10 April 2018 · Injury · TRANSFORM · MEDTRONIC, INC. · report 2182208-2018-00466
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE DEVICE ERODED FROM THE POCKET AND WAS VISIBLE AT A BREAK IN THE SKIN. CULTURES WERE TAKEN. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LDK, in Radiology, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.