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FDA 510(k)

Centerpiece Plate Fixation System

K-Number: K212428 · 2021-12-13

ApplicantMedtronic Sofamor Danek
Decision Date2021-12-13
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Centerpiece Plate Fixation System is a medical device manufactured by Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2021-12-13 under approval number K212428. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Centerpiece Plate Fixation System?

Centerpiece Plate Fixation System is a medical device that received FDA 510(k) clearance on 2021-12-13. It is manufactured by Medtronic Sofamor Danek. The 510(k) number is K212428.

When was Centerpiece Plate Fixation System approved by the FDA?

Centerpiece Plate Fixation System received FDA 510(k) clearance on 2021-12-13, under approval number K212428.

What company makes Centerpiece Plate Fixation System?

Centerpiece Plate Fixation System is manufactured by Medtronic Sofamor Danek.

What is the FDA product code for Centerpiece Plate Fixation System?

The FDA product code for Centerpiece Plate Fixation System is NQW.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING

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Related Devices (Code: NQW)

K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc. K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc. K181717Life Spine Laminoplasty SystemLife Spine, Inc. K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP K191927Hinged Laminoplasty SystemLife Spine, Inc.

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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