510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081404Substantially Equivalent

Spinal Integration Spinal-Eze Intraoperative Epidural Catheter Kit

Spinal Integration, LLC, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081404 is the FDA 510(k) clearance record for SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT, a class II device, cleared for Spinal Integration, LLC on under FDA product code BSO (Catheter, Conduction, Anesthetic). FDA records list one 510(k) clearance for Spinal Integration, LLC. As of , FDA records show no recalls naming K081404.

Clearance record

Decision date
Received
(155 days to decision)
Product code
BSO Catheter, Conduction, Anesthetic
Regulation
21 CFR 868.5120
Device class
Class II
Review panel
Anesthesiology
Applicant
Spinal Integration, LLC 6314 Kingspointe Pkwy. Unit 6, Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSO

Trailing 12 months

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

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