510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K031862Substantially Equivalent

Spinerx-Ldm

Spinerx Technology, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031862 is the FDA 510(k) clearance record for SPINERX-LDM, a class II device, cleared for Spinerx Technology on under FDA product code ITH (Equipment, Traction, Powered). FDA records list one 510(k) clearance for Spinerx Technology. As of , FDA records show no recalls naming K031862.

Clearance record

Decision date
Received
(137 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Spinerx Technology 6100 Brittmoore Rd., Houston TX
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