Cleared Special

K003076 - MITEK CUFFTACK

K003076 is the FDA 510(k) clearance for MITEK CUFFTACK by Mitek Products. It is a Class 2 Orthopedic device (product code MAI) cleared through the Special 510(k) pathway after a 24-day FDA review.

K003076 · Mitek Products · Orthopedic device
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Oct 2000
Decision
24d
Days
Class 2
Risk

K003076 is an FDA 510(k) clearance for the MITEK CUFFTACK. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Mitek Products (Norwood, US). The FDA issued a Cleared decision on October 27, 2000 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mitek Products devices

Submission Details

510(k) Number K003076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date October 27, 2000
Days to Decision 24 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 166
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K003076.
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