510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930629Substantially Equivalent

Acryl-X II System

Sonokinetics, Inc., Hoboken NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930629 is the FDA 510(k) clearance record for ACRYL-X II SYSTEM, a class II device, cleared for Sonokinetics, Inc. on under FDA product code LZV (System, Cement Removal Extraction). FDA records list 3 510(k) clearances for Sonokinetics, Inc., from to . As of , FDA records show no recalls naming K930629.

Clearance record

Decision date
Received
(347 days to decision)
Product code
LZV System, Cement Removal Extraction
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Applicant
Sonokinetics, Inc. 130 Washington St., Hoboken NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LZV

Trailing 12 months

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

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