Cleared Special

K032058 - MODIFICATION TO REPROCESSED SYNTHES EXT...

K032058 is an FDA 510(k) clearance for MODIFICATION TO REPROCESSED SYNTHES EXT..., manufactured by Alliance Medical Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 28-day FDA review.

K032058 · Alliance Medical Corp. · Orthopedic device
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Jul 2003
Decision
28d
Days
Class 2
Risk

K032058 is an FDA 510(k) clearance for the MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Alliance Medical Corp. (Phoenix, US). The FDA issued a Cleared decision on July 30, 2003 after a review of 28 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 Alliance Medical Corp. devices

FDA 510(k) Submission Details - K032058

510(k) Number K032058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2003
Decision Date July 30, 2003
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K032058.
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