510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243366Substantially Equivalent

DRX9000C-SL Cervical Spinal Decompression System

Excite Medical of Tampa Bay LLC, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243366 is the FDA 510(k) clearance record for DRX9000C-SL Cervical Spinal Decompression System, a class II device, cleared for Excite Medical of Tampa Bay, LLC on under FDA product code ITH (Equipment, Traction, Powered). FDA records list 2 510(k) clearances for Excite Medical of Tampa Bay, LLC, from to . As of , FDA records show no recalls naming K243366.

Clearance record

Decision date
Received
(233 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Excite Medical of Tampa Bay, LLC 4710 Eisenhower Blvd. N Suite A-12, Tampa FL
510(k) summary
Summary PDF
Third party review
No

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