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FDA 510(k)

ZIP™ MIS Interspinous Fusion System

K-Number: K221399 · 2022-07-08

ApplicantAurora Spine, Inc.
Decision Date2022-07-08
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, Inc.. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K221399. 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 2022-07-08. The listed applicant is Aurora Spine, Inc.. The 510(k) number is K221399.

When did ZIP™ MIS Interspinous Fusion System receive FDA 510(k) clearance?

ZIP™ MIS Interspinous Fusion System received FDA 510(k) clearance on 2022-07-08, under 510(k) number K221399.

Who is the listed applicant for ZIP™ MIS Interspinous Fusion System?

The FDA 510(k) record lists Aurora Spine, Inc. 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.

Other records listing Aurora 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.

K243865AERO MIS Facet Fusion SystemK221047SILO TFX MIS Sacroiliac Joint Fixation SystemK220610SOLO-LK210521DEXA-C Cervical Interbody SystemK210325APOLLO Anterior Cervical Plate (ACP) 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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