INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076— 510(k) K093675

Name: FDA 510(k) clearance K093675
Creator: U.S. Food and Drug Administration
Published: 2009-12-23

Substantially Equivalent

Vertebral Technologies, Inc.

FDA 510(k) clearance K093675 for INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076, Substantially Equivalent on 2009-12-23. Applicant: Vertebral Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Vertebral Technologies, Inc.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2009-11-27
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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K102277 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE2010-10-06
K091988 — MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 90762009-07-30

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.