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FDA 510(k)

restor3d MTP Implant

K-Number: K201393 · 2022-05-25

ApplicantRestor3D, Inc.
Decision Date2022-05-25
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

restor3d MTP Implant is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K201393. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the restor3d MTP Implant?

restor3d MTP Implant is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Restor3D, Inc.. The 510(k) number is K201393.

When did restor3d MTP Implant receive FDA 510(k) clearance?

restor3d MTP Implant received FDA 510(k) clearance on 2022-05-25, under 510(k) number K201393.

Who is the listed applicant for restor3d MTP Implant?

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

What is the FDA product code for restor3d MTP Implant?

The FDA product code for restor3d MTP Implant is KWD.

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: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLCK200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.

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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