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FDA 510(k)

Posterior Fusion Plate, HA Posterior Fusion Plate

K-Number: K200066 · 2020-12-10

ApplicantSpinal Simplicity, LLC
Decision Date2020-12-10
Product CodePEK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Posterior Fusion Plate, HA Posterior Fusion Plate is a medical device manufactured by Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2020-12-10 under approval number K200066. 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 Posterior Fusion Plate, HA Posterior Fusion Plate?

Posterior Fusion Plate, HA Posterior Fusion Plate is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Spinal Simplicity, LLC. The 510(k) number is K200066.

When was Posterior Fusion Plate, HA Posterior Fusion Plate approved by the FDA?

Posterior Fusion Plate, HA Posterior Fusion Plate received FDA 510(k) clearance on 2020-12-10, under approval number K200066.

What company makes Posterior Fusion Plate, HA Posterior Fusion Plate?

Posterior Fusion Plate, HA Posterior Fusion Plate is manufactured by Spinal Simplicity, LLC.

What is the FDA product code for Posterior Fusion Plate, HA Posterior Fusion Plate?

The FDA product code for Posterior Fusion Plate, HA Posterior Fusion Plate 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

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 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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