K142348 - OsteoSeal Bone Hemostat (FDA 510(k) Clearance)

K142348 is an FDA 510(k) clearance for the OsteoSeal Bone Hemostat. Classified as Wax, Bone (product code MTJ).

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 154 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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