SureMAX Family of Cervical Spacers— 510(k) K193359

Substantially Equivalent

Additive Implants, Inc.

FDA 510(k) clearance K193359 for SureMAX Family of Cervical Spacers, Substantially Equivalent on 2020-01-03. Applicant: Additive Implants, Inc..

Clearance details

Applicant: Additive Implants, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2019-12-04
Decision date: 2020-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Phoenix, AZ, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.