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

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..

Clearance details

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

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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.