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FDA 510(k)

restor3d Pin Implants

K-Number: K211789 · 2022-01-04

ApplicantRestor3D
Decision Date2022-01-04
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

restor3d Pin Implants is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2022-01-04 under 510(k) number K211789. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the restor3d Pin Implants?

restor3d Pin Implants is a medical device that received FDA 510(k) clearance on 2022-01-04. The listed applicant is Restor3D. The 510(k) number is K211789.

When did restor3d Pin Implants receive FDA 510(k) clearance?

restor3d Pin Implants received FDA 510(k) clearance on 2022-01-04, under 510(k) number K211789.

Who is the listed applicant for restor3d Pin Implants?

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 Pin Implants?

The FDA product code for restor3d Pin Implants is HTY.

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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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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