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FDA 510(k)

ZIP MIS INTERSPINOUS FUSION SYSTEM

K-Number: K133091 · 2013-11-27

ApplicantAurora Spine
Decision Date2013-11-27
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIP MIS INTERSPINOUS FUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine. It received FDA 510(k) clearance on 2013-11-27 under 510(k) number K133091. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIP MIS INTERSPINOUS FUSION SYSTEM?

ZIP MIS INTERSPINOUS FUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-27. The listed applicant is Aurora Spine. The 510(k) number is K133091.

When did ZIP MIS INTERSPINOUS FUSION SYSTEM receive FDA 510(k) clearance?

ZIP MIS INTERSPINOUS FUSION SYSTEM received FDA 510(k) clearance on 2013-11-27, under 510(k) number K133091.

Who is the listed applicant for ZIP MIS INTERSPINOUS FUSION SYSTEM?

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

What is the FDA product code for ZIP MIS INTERSPINOUS FUSION SYSTEM?

The FDA product code for ZIP MIS INTERSPINOUS FUSION SYSTEM is PEK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aurora Spine 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.

K243865AERO MIS Facet Fusion System

Related Devices (Code: PEK)

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.

K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLCK234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3Spinal Simplicity, LLCK233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLCK232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospineK231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.K223790Huvex Interspinous Fusion SystemDio Medical Corp.

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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