510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K962239Substantially Equivalent

Smart Adjuster (Sa201)

Sigma, Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962239 is the FDA 510(k) clearance record for SMART ADJUSTER (SA201), cleared for Sigma on under FDA product code LXM (Manipulator, Plunger-Like Joint). FDA records list one 510(k) clearance for Sigma. As of , FDA records show no recalls naming K962239.

Clearance record

Decision date
Received
(213 days to decision)
Product code
LXM Manipulator, Plunger-Like Joint
Device class
Unclassified
Review panel
Unknown
Applicant
Sigma 175 William Pitt Way, Pittsburgh PA
510(k) summary
Summary
Third party review
No

Clearances, product code LXM

Trailing 12 months

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

FDA records show no clearances under product code LXM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXM, 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