FDA.report

510(k) K232348

Device
RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System
Applicant
MiRus, LLC
510(k) number
K232348
Product code
OVE
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-27
Date received
2023-08-07
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jordan Bauman
Address
1755 W. Oak Pkwy. Suite 100 Marietta GA US 30062 30062

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code OVE

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K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis2025-09-25
K250540SABER-C SystemElevation Spine2025-08-08
K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC2025-07-30
K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation2025-06-27
K251117Cervical Spine Truss System (CSTS)4Web Medical2025-04-25
K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.2025-04-10
K243188CYLOX® STSignus Medizintechnik GmbH2025-02-11
K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine2025-02-07
K242517ProAM ACDF SystemPro Surgical, Inc.2024-11-20