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FDA 510(k)

Grappler Interference Screw System

K-Number: K241864 · 2024-07-25

ApplicantParagon 28, Inc.
Decision Date2024-07-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Grappler Interference Screw System is a medical device manufactured by Paragon 28, Inc.. It received FDA 510(k) clearance on 2024-07-25 under approval number K241864. 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 Grappler Interference Screw System?

Grappler Interference Screw System is a medical device that received FDA 510(k) clearance on 2024-07-25. It is manufactured by Paragon 28, Inc.. The 510(k) number is K241864.

When was Grappler Interference Screw System approved by the FDA?

Grappler Interference Screw System received FDA 510(k) clearance on 2024-07-25, under approval number K241864.

What company makes Grappler Interference Screw System?

Grappler Interference Screw System is manufactured by Paragon 28, Inc..

What is the FDA product code for Grappler Interference Screw System?

The FDA product code for Grappler Interference Screw System is MBI.

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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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