Cleared Traditional

K142348 - OsteoSeal Bone Hemostat

K142348 · Hemostasis, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
154d
Days
-
Risk

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.

View all Hemostasis, LLC devices

FDA 510(k) Submission Details - K142348

510(k) Number K142348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2014
Decision Date January 23, 2015
Days to Decision 154 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

MTJ Device Classification - Class 0,

Product Code MTJ Wax, Bone
Device Class -

Regulatory Peers - MTJ Wax, Bone

All 26
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