LDK

Device, Sensing, Optical Contour

Product code: LDK
Device name: Device, Sensing, Optical Contour
Device class: Class U
Medical specialty: Unknown
Marketing pathway: Enforcement Discretion
510(k) clearances (last 3 years): 2
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 8 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2023-11-15.

Number	Decision date	Applicant	Device name	Summary
K230463	2023-11-15	Nsite, Inc.	NSite Scoliosis Assessment App	PDF
K232023	2023-10-04	Momentum Health, Inc.	Momentum Spine	FDA

1 summaries are archived here for direct download.

Official FDA classification page: LDK

Classification and pathway per current FDA publications. Data from openFDA (CC0).