Extremity Staple— 510(k) K231458

Substantially Equivalent

Restor3D

FDA 510(k) clearance K231458 for Extremity Staple, Substantially Equivalent on 2023-08-03. Applicant: Restor3D.

Clearance details

Applicant: Restor3D
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2023-05-19
Decision date: 2023-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.