Cleared Special

K032739 - UCR SPINAL SYSTEM

K032739 is an FDA 510(k) clearance for UCR SPINAL SYSTEM, manufactured by Seaspine. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 77-day FDA review.

K032739 · Seaspine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
77d
Days
Class 2
Risk

K032739 is an FDA 510(k) clearance for the UCR SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Seaspine (San Diego, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 77 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.

FDA 510(k) Submission Details - K032739

510(k) Number K032739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2003
Decision Date November 20, 2003
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K032739.
REVOLUTION SPINAL FIXATION SYSTEM
K032219 · Spinal Innovations, Inc. · Dec 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc. · Dec 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · Ortho Tec, LLC · Nov 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · Medtronic Sofamor Danek · Nov 2003
PLUS PIVOT LINK UNIVERSAL SYSTEM
K032398 · Spine Vision, Inc. · Oct 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455 · Signus Medical, LLC · Oct 2003
K032739 · UCR SPINAL SYSTEM
Download PDF FDA Summary Seaspine