My3D® Personalized Pelvic Reconstruction— 510(k) K212815

Name: FDA 510(k) clearance K212815
Creator: U.S. Food and Drug Administration
Published: 2022-07-06

Substantially Equivalent

Onkos Surgical

FDA 510(k) clearance K212815 for My3D® Personalized Pelvic Reconstruction, Substantially Equivalent on 2022-07-06. Applicant: Onkos Surgical. Device class: 2.

Clearance details

Applicant: Onkos Surgical
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2021-09-03
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.