Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate

FDA 510(k) K212781 · Spinal Simplicity, LLC

Substantially Equivalent

510(k) numberK212781

Submission

Device name
Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate
Applicant
Spinal Simplicity, LLC
Overland Park, KS, US
Received
September 1, 2021
Decision date
December 15, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PEK – Spinous Process Plate
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Specialty
Orthopedic
Implant
Yes

A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…

Other 510(k)s with product code PEK

510(k)DeviceApplicantDecision
K253250Minuteman® G6 MIS Fusion PlatePEK · Traditional Spinal Simplicity, LLC12/01/2025SE
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…PEK · Special Spinal Simplicity, LLC01/18/2024SE
K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…PEK · Special Spinal Simplicity, LLC11/29/2023SE
K232484KeyLift™ Expandable Interlaminar Stabilization SystemPEK · Traditional Amplio Spine, LLC10/19/2023SE
K231807primaLOK™ SP Interspinous Fusion SystemPEK · Traditional Wenzel Spine, Inc.08/15/2023SE
K223790Huvex Interspinous Fusion SystemPEK · Traditional Dio Medical Corp.03/09/2023SE
K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…PEK · Traditional Spinal Simplicity, LLC08/19/2022SE
K221399ZIP™ MIS Interspinous Fusion SystemPEK · Traditional Aurora Spine, Inc.07/08/2022SE
K211880Minuteman G5 MIS Fusion PlatePEK · Traditional Spinal Simplicity, LLC03/11/2022SE
K213266Inspan ScrewLES Fusion SystemPEK · Traditional Lespine Innovations, LLC12/03/2021SE

More from Lespine Innovations, LLC

510(k)DeviceDecision
K253523Freedom DS™ Decompression SystemHRX · Traditional 04/16/2026SE
K253250Minuteman® G6 MIS Fusion PlatePEK · Traditional 12/01/2025SE
K250001Patriot SI Implant SystemOUR · Traditional 06/03/2025SE
K240592Wolff's Law Anterior Cervical Plate SystemKWQ · Traditional 05/24/2024SE
K232259Patriot-SI Posterior Implant SystemOUR · Traditional 04/19/2024SE
K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…PEK · Special 01/18/2024SE
K231923Liberty SI Lateral Implant SystemOUR · Traditional 12/05/2023SE
K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…PEK · Special 11/29/2023SE
K221307Edge Upper Cervical SystemNKG · Traditional 07/10/2023SE
K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…PEK · Traditional 08/19/2022SE

Questions and answers

When was Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate cleared by the FDA?

Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate (K212781) received a 510(k) decision of Substantially Equivalent on December 15, 2021, 105 days after the submission was received.

What is the product code of K212781?

The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.