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FDA 510(k)

Minuteman G5 MIS Fusion Plate

K-Number: K211880 · 2022-03-11

ApplicantSpinal Simplicity, LLC
Decision Date2022-03-11
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Minuteman G5 MIS Fusion Plate is a medical device manufactured by Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2022-03-11 under approval number K211880. 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 Minuteman G5 MIS Fusion Plate?

Minuteman G5 MIS Fusion Plate is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Spinal Simplicity, LLC. The 510(k) number is K211880.

When was Minuteman G5 MIS Fusion Plate approved by the FDA?

Minuteman G5 MIS Fusion Plate received FDA 510(k) clearance on 2022-03-11, under approval number K211880.

What company makes Minuteman G5 MIS Fusion Plate?

Minuteman G5 MIS Fusion Plate is manufactured by Spinal Simplicity, LLC.

What is the FDA product code for Minuteman G5 MIS Fusion Plate?

The FDA product code for Minuteman G5 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, LLC

K200066Posterior Fusion Plate, HA Posterior Fusion Plate K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 K231923Liberty SI Lateral Implant System K233527Minuteman 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 Plate K221307Edge Upper Cervical System

View all 12 devices →

Related Devices (Code: PEK)

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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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