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FDA 510(k)

Curiteva Sacroiliac Joint Fusion System

K-Number: K210402 · 2021-09-09

ApplicantCuriteva, Inc.
Decision Date2021-09-09
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Curiteva Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K210402. 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 Curiteva Sacroiliac Joint Fusion System?

Curiteva Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Curiteva, Inc.. The 510(k) number is K210402.

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

Curiteva Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2021-09-09, under 510(k) number K210402.

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

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

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

The FDA product code for Curiteva 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 Curiteva, 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.

K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemK254061Curiteva Porous PEEK Cervical Interbody Fusion SystemK250845Curiteva Porous PEEK Standalone ALIF SystemK243137Curiteva Porous PEEK Laminoplasty SystemK233360Curiteva Thoracolumbar Plate SystemK233744Curiteva Porous PEEK Lumbar Interbody Fusion System

View all 15 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.

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