510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230463Substantially Equivalent

NSite Scoliosis Assessment App

Nsite, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230463 is the FDA 510(k) clearance record for NSite Scoliosis Assessment App, cleared for Nsite, Inc. on under FDA product code LDK (Device, Sensing, Optical Contour). FDA records list one 510(k) clearance for Nsite, Inc. As of , FDA records show no recalls naming K230463.

Clearance record

Decision date
Received
(267 days to decision)
Product code
LDK Device, Sensing, Optical Contour
Device class
Unclassified
Review panel
Unknown
Applicant
Nsite, Inc. 821 Stanford Ave., Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LDK

Trailing 12 months

FDA records hold no clearances under product code LDK in the trailing twelve months.

FDA records show no clearances under product code LDK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260