FDA 510(k)

Pegasus System

K-Number: K191345 · 2019-07-17

Decision Date2019-07-17

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Pegasus System is a medical device manufactured by A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2019-07-17 under approval number K191345. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pegasus System?

Pegasus System is a medical device that received FDA 510(k) clearance on 2019-07-17. It is manufactured by A.M. Surgical, Inc.. The 510(k) number is K191345.

When was Pegasus System approved by the FDA?

Pegasus System received FDA 510(k) clearance on 2019-07-17, under approval number K191345.

What company makes Pegasus System?

Pegasus System is manufactured by A.M. Surgical, Inc..

What is the FDA product code for Pegasus System?

The FDA product code for Pegasus System is HRX.

Other Devices by A.M. Surgical, Inc.

K180087A.M. Surgical Intramedullary Fixation Device K191771SECURE Screw

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.