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

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..

Clearance details

Applicant: Centermed, Inc.
Product code: Code PBF
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 ↗

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.