510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K071347Substantially Equivalent

Vax-D Genesis G2 System

Vax-D Medical Technologies, LLC, Oldsmar FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071347 is the FDA 510(k) clearance record for VAX-D GENESIS G2 SYSTEM, a class II device, cleared for Vax-D Medical Technologies, LLC on under FDA product code ITH (Equipment, Traction, Powered). FDA records list one 510(k) clearance for Vax-D Medical Technologies, LLC. As of , FDA records show no recalls naming K071347.

Clearance record

Decision date
Received
(144 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Vax-D Medical Technologies, LLC 310 Mears Blvd., Oldsmar FL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code ITH

Trailing 12 months

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

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