Cleared Traditional

K030958 - ORIA SPINAL SYSTEM

K030958 is an FDA 510(k) clearance for ORIA SPINAL SYSTEM, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K030958 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2003
Decision
238d
Days
Class 2
Risk

K030958 is an FDA 510(k) clearance for the ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Ortho Tec, LLC (California, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 238 days - an extended review cycle.

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 Ortho Tec, LLC devices

FDA 510(k) Submission Details - K030958

510(k) Number K030958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2003
Decision Date November 20, 2003
Days to Decision 238 days
Submission Type Traditional
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
116d slower than avg
Panel avg: 122d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 193
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K030958.
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · Blackstone Medical, Inc. · Feb 2004
POSTERIOR CABLE SCREW
K022908 · Pioneer Surgical Technology · Jan 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc. · Dec 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · Medtronic Sofamor Danek · Nov 2003
TSRH SPINAL SYSTEM
K031967 · Medtronic Sofamor Danek, Inc. · Sep 2003
TSRH SPINAL SYSTEM
K032578 · Medtronic Sofamor Danek, Inc. · Sep 2003