CenterMed Patient Matched Assisted Surgical Planning (ASP) System— 510(k) K211614

Name: FDA 510(k) clearance K211614
Creator: U.S. Food and Drug Administration
Published: 2022-08-04

Substantially Equivalent

Centermed, Inc.

FDA 510(k) clearance K211614 for CenterMed Patient Matched Assisted Surgical Planning (ASP) System, Substantially Equivalent on 2022-08-04. Applicant: Centermed, Inc.. Device class: 2.

Clearance details

Applicant: Centermed, Inc.
Product code: Code PBF
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2021-05-26
Decision date: 2022-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walnut Creek, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PBF

product code PBF

Injury: 180
Total: 180

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.