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FDA 510(k)

Extremity Staple

K-Number: K231458 · 2023-08-03

ApplicantRestor3D
Decision Date2023-08-03
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Extremity Staple is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2023-08-03 under approval number K231458. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extremity Staple?

Extremity Staple is a medical device that received FDA 510(k) clearance on 2023-08-03. It is manufactured by Restor3D. The 510(k) number is K231458.

When was Extremity Staple approved by the FDA?

Extremity Staple received FDA 510(k) clearance on 2023-08-03, under approval number K231458.

What company makes Extremity Staple?

Extremity Staple is manufactured by Restor3D.

What is the FDA product code for Extremity Staple?

The FDA product code for Extremity Staple is JDR.

Related Clinical Trials

NCT07563803 The restor3d Outcomes Registry NOT_YET_RECRUITING

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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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