FDA 510(k)

restor3d MTP Implant

K-Number: K201393 · 2022-05-25

Decision Date2022-05-25

Product CodeKWD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

restor3d MTP Implant is a medical device manufactured by Restor3D, Inc.. It received FDA 510(k) clearance on 2022-05-25 under approval 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. It is manufactured by Restor3D, Inc.. The 510(k) number is K201393.

When was restor3d MTP Implant approved by the FDA?

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

What company makes restor3d MTP Implant?

restor3d MTP Implant is manufactured by Restor3D, Inc..

What is the FDA product code for restor3d MTP Implant?

The FDA product code for restor3d MTP Implant is KWD.

Related Clinical Trials

NCT07563803 The restor3d Outcomes Registry NOT_YET_RECRUITING

Other Devices by Restor3D, Inc.

K201314Restor3d Utility Wedge K240591restor3d Kinos Axiom Total Ankle System K252067Velora Acetabular System K243768iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System K242356TIDAL Fusion Cage System

Related Devices (Code: KWD)

K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc. K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc. K190261BOSS Toe Fixation SystemArthrosurface, Inc. K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc. K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc. K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.