510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K112709Substantially Equivalent

Stimulation/dissection Instruments

Nu Vasive, Incorporated, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112709 is the FDA 510(k) clearance record for STIMULATION/DISSECTION INSTRUMENTS, a class II device, cleared for Nu Vasive, Incorporated on under FDA product code ETN (Stimulator, Nerve). FDA records list 112 510(k) clearances for Nu Vasive, Incorporated, from to . As of , FDA records show no recalls naming K112709.

Clearance record

Decision date
Received
(143 days to decision)
Product code
ETN Stimulator, Nerve
Regulation
21 CFR 874.1820
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Nu Vasive, Incorporated 7475 Lusk Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETN

Trailing 12 months
2 clearances under product code ETN in the twelve months to November 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260