IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION— 510(k) K092381

Name: FDA 510(k) clearance K092381
Creator: U.S. Food and Drug Administration
Published: 2009-10-27

Substantially Equivalent

Ibalance Medical, Inc.

FDA 510(k) clearance K092381 for IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION, Substantially Equivalent on 2009-10-27. Applicant: Ibalance Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ibalance Medical, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2009-08-05
Decision date: 2009-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philedelphia, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.