510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K082992Substantially Equivalent

Axxion Light Guide

Spinal Elements, Inc, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082992 is the FDA 510(k) clearance record for AXXION LIGHT GUIDE, a class II device, cleared for Spinal Elements, Inc. on under FDA product code FST (Light, Surgical, Fiberoptic). FDA records list 66 510(k) clearances for Spinal Elements, Inc., from to . As of , FDA records show no recalls naming K082992.

Clearance record

Decision date
Received
(134 days to decision)
Product code
FST Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Spinal Elements, Inc. 2744 Loker Ave. W. Suite 100, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FST

Trailing 12 months

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

FDA records show no clearances under product code FST in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FST, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260