510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160278Substantially Equivalent

VSTAAR AdjusteR

Spinal Acoustics, LLC, Beaver PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160278 is the FDA 510(k) clearance record for VSTAAR AdjusteR, cleared for Spinal Acoustics, LLC on under FDA product code LXM (Manipulator, Plunger-Like Joint). FDA records list one 510(k) clearance for Spinal Acoustics, LLC. As of , FDA records show no recalls naming K160278.

Clearance record

Decision date
Received
(276 days to decision)
Product code
LXM Manipulator, Plunger-Like Joint
Device class
Unclassified
Review panel
Unknown
Applicant
Spinal Acoustics, LLC 640 Fourth St., Beaver PA
510(k) summary
Summary PDF
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