Patient Specific Marking Guides— 510(k) K211076

Substantially Equivalent

Additive Orthopaedics, LLC

FDA 510(k) clearance K211076 for Patient Specific Marking Guides, Substantially Equivalent on 2022-06-28. Applicant: Additive Orthopaedics, LLC.

Clearance details

Applicant: Additive Orthopaedics, LLC
Product code: Code PBF
Advisory panel: Orthopedic
Date received: 2021-04-12
Decision date: 2022-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Beach, NJ, 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.