510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002677Substantially Equivalent

Nuvasive Ins-1 Intraoperative Nerve Surveillance System

NuVasive Inc, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002677 is the FDA 510(k) clearance record for NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM, a class II device, cleared for Nuvasive, Inc. on under FDA product code BXM (Stimulator, Nerve, Ac-Powered). FDA records list 92 510(k) clearances for Nuvasive, Inc., from to . As of , FDA records show no recalls naming K002677.

Clearance record

Decision date
Received
(77 days to decision)
Product code
BXM Stimulator, Nerve, Ac-Powered
Regulation
21 CFR 868.2775
Device class
Class II
Review panel
Anesthesiology
Applicant
Nuvasive, Inc. 10065 Old Grove Rd., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code BXM

Trailing 12 months

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

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