510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232348Substantially Equivalent

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

Mirus, LLC, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232348 is the FDA 510(k) clearance record for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System, a class II device, cleared for MiRus, LLC on under FDA product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical). FDA's definition for product code OVE reads: "Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". FDA records list 24 510(k) clearances for MiRus, LLC, from to . As of , FDA records show no recalls naming K232348.

Clearance record

Decision date
Received
(81 days to decision)
Product code
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
MiRus, LLC 1755 W. Oak Pkwy., Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVE

Trailing 12 months
13 clearances under product code OVE in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code OVE, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20263
May 20260
June 20263
July 20262
August 20261
September 20261
October 20260