Cleared Special

K030377 - MODIFICATION TO SYNTHES CERVIFIX SYSTEM

K030377 is the FDA 510(k) clearance for MODIFICATION TO SYNTHES CERVIFIX SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 29-day FDA review.

K030377 · Synthes (Usa) · Orthopedic device
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Mar 2003
Decision
29d
Days
Class 2
Risk

K030377 is an FDA 510(k) clearance for the MODIFICATION TO SYNTHES CERVIFIX SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K030377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2003
Decision Date March 06, 2003
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 152
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K030377.
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · Medtronic Sofamor Danek, Inc. · May 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · Blackstone Medical, Inc. · Apr 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · Synthes (Usa) · Mar 2003
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103 · Depuyacromed · Feb 2003
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
K023644 · Spinal Concepts, Inc. · Nov 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · Medtronic Sofamor Danek, Inc. · Sep 2002