FDA 510(k)

Restor3d Utility Wedge

K-Number: K201314 · 2021-06-17

Decision Date2021-06-17

Product CodePLF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Restor3d Utility Wedge is a medical device manufactured by Restor3D, Inc.. It received FDA 510(k) clearance on 2021-06-17 under approval number K201314. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restor3d Utility Wedge?

Restor3d Utility Wedge is a medical device that received FDA 510(k) clearance on 2021-06-17. It is manufactured by Restor3D, Inc.. The 510(k) number is K201314.

When was Restor3d Utility Wedge approved by the FDA?

Restor3d Utility Wedge received FDA 510(k) clearance on 2021-06-17, under approval number K201314.

What company makes Restor3d Utility Wedge?

Restor3d Utility Wedge is manufactured by Restor3D, Inc..

What is the FDA product code for Restor3d Utility Wedge?

The FDA product code for Restor3d Utility Wedge is PLF.

Other Devices by Restor3D, Inc.

K201393restor3d MTP Implant 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: PLF)

K171327Tyber Medical Wedge SystemTyber Medical, LLC K162241TITAN 3-D Wedge SystemParagon 28 K192645Trigon Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. K191047ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc. K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.

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.