restor3d MTP Implant— 510(k) K201393

Substantially Equivalent

Restor3D, Inc.

FDA 510(k) clearance K201393 for restor3d MTP Implant, Substantially Equivalent on 2022-05-25. Applicant: Restor3D, Inc..

Clearance details

Applicant: Restor3D, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2020-05-27
Decision date: 2022-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.