Cleared Traditional

K842845 - BONE MILL BONE GRINDER (FDA 510(k) Clearance)

K842845 · Acromed Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
97d
Days
-
Risk

K842845 is an FDA 510(k) clearance for the BONE MILL BONE GRINDER.

Submitted by Acromed Corp. (Cleveland, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 97 days - within the typical 510(k) review window.

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 Acromed Corp. devices

Submission Details

510(k) Number K842845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date October 25, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 114d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -