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FDA 510(k)

TopLock Anchor System

K-Number: K193377 · 2020-11-25

ApplicantFusion Orthopedics, LLC
Decision Date2020-11-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TopLock Anchor System is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2020-11-25 under approval number K193377. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TopLock Anchor System?

TopLock Anchor System is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K193377.

When was TopLock Anchor System approved by the FDA?

TopLock Anchor System received FDA 510(k) clearance on 2020-11-25, under approval number K193377.

What company makes TopLock Anchor System?

TopLock Anchor System is manufactured by Fusion Orthopedics, LLC.

What is the FDA product code for TopLock Anchor System?

The FDA product code for TopLock Anchor System is MBI.

Related Clinical Trials

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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