OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070— 510(k) K133583

Name: FDA 510(k) clearance K133583
Creator: U.S. Food and Drug Administration
Published: 2014-02-10

Substantially Equivalent

Interventional Spine, Inc.

FDA 510(k) clearance K133583 for OPTICAGE INTERBODY FUSION DEVICE, MODEL SERIES 9070, Substantially Equivalent on 2014-02-10. Applicant: Interventional Spine, Inc.. Device class: 2.

Clearance details

Applicant: Interventional Spine, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2013-11-21
Decision date: 2014-02-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K132479 — OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-002013-09-19
K113527 — OPTICAGE INTERBODY FUSION DEVICE2012-01-20

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.