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FDA 510(k)

restor3d Metallic Interference Screw

K-Number: K193491 · 2020-03-19

ApplicantRestor3D
Decision Date2020-03-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

restor3d Metallic Interference Screw is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K193491. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the restor3d Metallic Interference Screw?

restor3d Metallic Interference Screw is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is Restor3D. The 510(k) number is K193491.

When did restor3d Metallic Interference Screw receive FDA 510(k) clearance?

restor3d Metallic Interference Screw received FDA 510(k) clearance on 2020-03-19, under 510(k) number K193491.

Who is the listed applicant for restor3d Metallic Interference Screw?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for restor3d Metallic Interference Screw?

The FDA product code for restor3d Metallic Interference Screw is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITING

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Related Devices (Code: HWC)

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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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