510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111462Substantially Equivalent

Fixate Tissue Band

Anulex Technologies, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111462 is the FDA 510(k) clearance record for FIXATE TISSUE BAND, a class II device, cleared for Anulex Technologies, Inc. on under FDA product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)). FDA records list 12 510(k) clearances for Anulex Technologies, Inc., from to . As of , FDA records show no recalls naming K111462.

Clearance record

Decision date
Received
(105 days to decision)
Product code
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Regulation
21 CFR 882.5880
Device class
Class II
Review panel
Neurology
Applicant
Anulex Technologies, Inc. 5600 Rowland Rd., Suite 280, Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GZB

Trailing 12 months

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

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