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FDA 510(k)

REUNION Sacroiliac Joint Fusion System

K-Number: K232211 · 2023-10-24

ApplicantAstura Medical
Decision Date2023-10-24
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REUNION Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232211. 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 REUNION Sacroiliac Joint Fusion System?

REUNION Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Astura Medical. The 510(k) number is K232211.

When did REUNION Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

REUNION Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232211.

Who is the listed applicant for REUNION Sacroiliac Joint Fusion System?

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

What is the FDA product code for REUNION Sacroiliac Joint Fusion System?

The FDA product code for REUNION Sacroiliac Joint Fusion System 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.

NCT05367505Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the PelvisACTIVE_NOT_RECRUITINGNCT05870488iFuse TORQ for the Treatment of Sacroiliac Joint DysfunctionACTIVE_NOT_RECRUITINGNCT06909292Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1COMPLETEDNCT07565545Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness OutcomesNOT_YET_RECRUITING

Other records listing Astura Medical 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.

K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemK252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemK243259MASADA Modular Spinal Fixation SystemK240160EGPS Navigated InstrumentsK233359DOMINION Expandable Corpectomy SystemK231694MASADA Modular Spinal Fixation System

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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.

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