INFILL GRAFT DELIVERY SYSTEM— 510(k) K121476

Name: FDA 510(k) clearance K121476
Creator: U.S. Food and Drug Administration
Published: 2012-08-29

Substantially Equivalent

Pinnacle Spine Group, LLC

FDA 510(k) clearance K121476 for INFILL GRAFT DELIVERY SYSTEM, Substantially Equivalent on 2012-08-29. Applicant: Pinnacle Spine Group, LLC. Device class: 2.

Clearance details

Applicant: Pinnacle Spine Group, LLC
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2012-05-18
Decision date: 2012-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.