FDA 510(k)

HA Minuteman G3-R MIS Fusion Plate

K-Number: K163428 · 2017-02-02

Decision Date2017-02-02

Product CodePEK

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HA Minuteman G3-R MIS Fusion Plate is a medical device manufactured by Spinal Simplicity. It received FDA 510(k) clearance on 2017-02-02 under approval number K163428. 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 HA Minuteman G3-R MIS Fusion Plate?

HA Minuteman G3-R MIS Fusion Plate is a medical device that received FDA 510(k) clearance on 2017-02-02. It is manufactured by Spinal Simplicity. The 510(k) number is K163428.

When was HA Minuteman G3-R MIS Fusion Plate approved by the FDA?

HA Minuteman G3-R MIS Fusion Plate received FDA 510(k) clearance on 2017-02-02, under approval number K163428.

What company makes HA Minuteman G3-R MIS Fusion Plate?

HA Minuteman G3-R MIS Fusion Plate is manufactured by Spinal Simplicity.

What is the FDA product code for HA Minuteman G3-R MIS Fusion Plate?

The FDA product code for HA Minuteman G3-R MIS Fusion Plate is PEK.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Other Devices by Spinal Simplicity

K253523Freedom DS Decompression System

Related Devices (Code: PEK)

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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.