510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121922Substantially Equivalent

Beacon Stabilization System

Globus Medical, Inc., Audubon PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121922 is the FDA 510(k) clearance record for BEACON STABILIZATION SYSTEM, a class II device, cleared for Globus Medical, Inc. on under FDA product code NKB (Thoracolumbosacral Pedicle Screw System). FDA's definition for product code NKB reads: "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion". FDA records list 217 510(k) clearances for Globus Medical, Inc., from to . As of , FDA records show no recalls naming K121922.

Clearance record

Decision date
Received
(24 days to decision)
Product code
NKB Thoracolumbosacral Pedicle Screw System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Globus Medical, Inc. 2560 General Armistead Ave., Audubon PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NKB

Trailing 12 months
32 clearances under product code NKB in the twelve months to November 2026, September 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code NKB, trailing twelve months
MonthClearances
December 20252
January 20263
February 20263
March 20260
April 20265
May 20264
June 20262
July 20264
August 20260
September 20267
October 20262
November 20260