510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021502Substantially Equivalent

Oscar, Model Oe3000

Orthosonics, Ltd., Brookeville MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021502 is the FDA 510(k) clearance record for OSCAR, MODEL OE3000, a class II device, cleared for Orthosonics, Ltd. on under FDA product code LZV (System, Cement Removal Extraction). FDA records list 4 510(k) clearances for Orthosonics, Ltd., from to . As of , FDA records show no recalls naming K021502.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LZV System, Cement Removal Extraction
Regulation
21 CFR 888.4580
Device class
Class II
Review panel
Orthopedic
Applicant
Orthosonics, Ltd. 2305 Gold Mine Rd., Brookeville MD
510(k) summary
Summary PDF
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