Cleared Traditional

K892903 - MITEK ANCHOR DRILL (FDA 510(k) Clearance)

Class I Orthopedic device.

K892903 · Mitek Surgical Products, Inc. · Orthopedic device
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Oct 1989
Decision
169d
Days
Class 1
Risk

K892903 is an FDA 510(k) clearance for the MITEK ANCHOR DRILL. Classified as Bit, Drill (product code HTW), Class I - General Controls.

Submitted by Mitek Surgical Products, Inc. (Dedham, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 169 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K892903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date October 06, 1989
Days to Decision 169 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTW Bit, Drill
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.