6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED— 510(k) K122123

Name: FDA 510(k) clearance K122123
Creator: U.S. Food and Drug Administration
Published: 2012-10-02

Substantially Equivalent

Depuy Mitek, Inc., A Johnson and Johnson Company

FDA 510(k) clearance K122123 for 6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED, Substantially Equivalent on 2012-10-02. Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company. Device class: 2.

Clearance details

Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2012-07-18
Decision date: 2012-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.