Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

K-Number: K183119 · 2019-02-06

ApplicantGlobus Medical, Inc.
Decision Date2019-02-06
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2019-02-06 under 510(k) number K183119. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments?

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments is a medical device that received FDA 510(k) clearance on 2019-02-06. The listed applicant is Globus Medical, Inc.. The 510(k) number is K183119.

When did SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments receive FDA 510(k) clearance?

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments received FDA 510(k) clearance on 2019-02-06, under 510(k) number K183119.

Who is the listed applicant for SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments?

The FDA product code for SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments is OUR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07589023A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic ScoliosisNOT_YET_RECRUITINGNCT05367505Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the PelvisACTIVE_NOT_RECRUITINGNCT07628010Modern Methods of Treatment and Diagnosis of Patients With Injuries and Diseases of the Musculoskeletal SystemACTIVE_NOT_RECRUITING

Other records listing Globus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254043TRIVANCE™ Hip StemK262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ SystemK253401SCRIPT™ Implant SystemK261043AUTOBAHN™ Nailing SystemK252166RIB LINK™ Fixation System

View all 93 devices →

Related Devices (Code: OUR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑