Cleared Traditional

K912843 - FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE (FDA 510(k) Clearance)

Class I Orthopedic device.

K912843 · Flexmedics · Orthopedic device
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Sep 1991
Decision
90d
Days
Class 1
Risk

K912843 is an FDA 510(k) clearance for the FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE. Classified as Probe (product code HXB), Class I - General Controls.

Submitted by Flexmedics (Minneapolis, US). The FDA issued a Cleared decision on September 24, 1991 after a review of 90 days - within the typical 510(k) review window.

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 Flexmedics devices

Submission Details

510(k) Number K912843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1991
Decision Date September 24, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXB Probe
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.