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FDA 510(k)

ZESPIN SI Joint Fusion System

K-Number: K223521 · 2023-01-20

ApplicantAegis Spine, Inc.
Decision Date2023-01-20
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZESPIN SI Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Aegis Spine, Inc.. It received FDA 510(k) clearance on 2023-01-20 under 510(k) number K223521. 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 ZESPIN SI Joint Fusion System?

ZESPIN SI Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-20. The listed applicant is Aegis Spine, Inc.. The 510(k) number is K223521.

When did ZESPIN SI Joint Fusion System receive FDA 510(k) clearance?

ZESPIN SI Joint Fusion System received FDA 510(k) clearance on 2023-01-20, under 510(k) number K223521.

Who is the listed applicant for ZESPIN SI Joint Fusion System?

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

What is the FDA product code for ZESPIN SI Joint Fusion System?

The FDA product code for ZESPIN SI Joint Fusion System is OUR.

Other records listing Aegis Spine, 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.

K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemK221719ABTross ALIF Expandable Cage SystemK221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate SystemK210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate SystemK203531XYPAN Expandable Lumbar Cage System

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

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

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