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FDA 510(k)

Minuteman 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

K-Number: K234051 · 2024-01-18

ApplicantSpinal Simplicity, LLC
Decision Date2024-01-18
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Minuteman 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 is a medical device manufactured by Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2024-01-18 under approval number K234051. 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 G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3?

Minuteman 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 is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Spinal Simplicity, LLC. The 510(k) number is K234051.

When was Minuteman 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 approved by the FDA?

Minuteman 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 received FDA 510(k) clearance on 2024-01-18, under approval number K234051.

What company makes Minuteman 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?

Minuteman 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 is manufactured by Spinal Simplicity, LLC.

What is the FDA product code for Minuteman 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?

The FDA product code for Minuteman 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 is PEK.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT07565545 Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes NOT_YET_RECRUITING NCT05323448 Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion. COMPLETED

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 K211880Minuteman G5 MIS Fusion Plate 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

View all 12 devices →

Related Devices (Code: PEK)

K161016Z-Clamp ISP SystemZavation, LLC K153302coflex-IFParadigm Spine, LLC K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc. K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC K162849Huvex Interspinous Fixation SystemDio Medical Co., Ltd.

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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