Opticage(R) Expandable Interbody Fusion Device— 510(k) K160464

Substantially Equivalent

Interventional Spine, Inc.

FDA 510(k) clearance K160464 for Opticage(R) Expandable Interbody Fusion Device, Substantially Equivalent on 2016-04-04. Applicant: Interventional Spine, Inc..

Clearance details

Applicant: Interventional Spine, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2016-02-19
Decision date: 2016-04-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.