Cleared Traditional

K080841 - COSMIC SYSTEM

K080841 is the FDA 510(k) clearance for COSMIC SYSTEM by Ulrich GmbH & Co. KG. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K080841 · Ulrich GmbH & Co. KG · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
119d
Days
Class 2
Risk

K080841 is an FDA 510(k) clearance for the COSMIC SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Ulrich GmbH & Co. KG (St. Louis, US). The FDA issued a Cleared decision on July 23, 2008 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Ulrich GmbH & Co. KG devices

Submission Details

510(k) Number K080841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2008
Decision Date July 23, 2008
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 160
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K080841.
PILOT SPINAL SYSTEM
K083865 · Life Spine · Jan 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · Alphatec Spine, Inc. · Jul 2008
CONQUEST SPINAL SYSTEM
K080767 · Life Spine · May 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · Spine Wave, Inc. · May 2008