SureMAX-SA Cervical Standalone System— 510(k) K211111

Name: FDA 510(k) clearance K211111
Creator: U.S. Food and Drug Administration
Published: 2021-07-16

Substantially Equivalent

Additive Implants, Inc.

FDA 510(k) clearance K211111 for SureMAX-SA Cervical Standalone System, Substantially Equivalent on 2021-07-16. Applicant: Additive Implants, Inc.. Device class: 2.

Clearance details

Applicant: Additive Implants, Inc.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-04-14
Decision date: 2021-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

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K193359 — SureMAX Family of Cervical Spacers2020-01-03

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.