PARAMOUNT R IBF DEVICE— 510(k) K103228

Name: FDA 510(k) clearance K103228
Creator: U.S. Food and Drug Administration
Published: 2011-01-05

Substantially Equivalent

Theken Spine, LLC

FDA 510(k) clearance K103228 for PARAMOUNT R IBF DEVICE, Substantially Equivalent on 2011-01-05. Applicant: Theken Spine, LLC. Device class: 2.

Clearance details

Applicant: Theken Spine, LLC
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2010-11-02
Decision date: 2011-01-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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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.