Cleared Traditional

K082384 - HAV-LOK BUNION CORRECTION SYSTEM

K082384 is an FDA 510(k) clearance for HAV-LOK BUNION CORRECTION SYSTEM, manufactured by Instratek, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K082384 · Instratek, Inc. · Orthopedic device
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Dec 2008
Decision
111d
Days
Class 2
Risk

K082384 is an FDA 510(k) clearance for the HAV-LOK BUNION CORRECTION SYSTEM. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Instratek, Inc. (Spring, US). The FDA issued a Cleared decision on December 8, 2008 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Instratek, Inc. devices

FDA 510(k) Submission Details - K082384

510(k) Number K082384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date December 08, 2008
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HTN Washer, Bolt Nut

All 71
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