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FDA 510(k)

Superelastic Staple

K-Number: K192447 · 2020-02-28

ApplicantNeosteo
Decision Date2020-02-28
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Superelastic Staple is a medical device manufactured by Neosteo. It received FDA 510(k) clearance on 2020-02-28 under approval number K192447. 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 Superelastic Staple?

Superelastic Staple is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Neosteo. The 510(k) number is K192447.

When was Superelastic Staple approved by the FDA?

Superelastic Staple received FDA 510(k) clearance on 2020-02-28, under approval number K192447.

What company makes Superelastic Staple?

Superelastic Staple is manufactured by Neosteo.

What is the FDA product code for Superelastic Staple?

The FDA product code for Superelastic Staple is JDR.

Other Devices by Neosteo

K191424Interphalangeal Joint Fusion Device Range K212545FlexitSystem Knee osteotomy system

Related Devices (Code: JDR)

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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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