Cleared Traditional

K950865 - ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOL...

K950865 is the FDA 510(k) clearance for ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOL... by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K950865 · Smith & Nephew Richards, Inc. · Orthopedic device
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Sep 1995
Decision
186d
Days
Class 2
Risk

K950865 is an FDA 510(k) clearance for the ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH T.... Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 186 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K950865 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 27, 1995
Decision Date September 01, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 122d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 156
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K950865.
ISOLA SYSTEM
K952236 · Acromed Corp. · Jan 1996
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635 · Sofamor Danek USA,Inc. · Oct 1995
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995
GDLH POSTERIOR SPINAL SYSTEM
K950596 · Sofamor Danek USA,Inc. · Aug 1995
PARAGON POSTERIOR SPINAL SYSTEM
K950955 · Sofamor Danek USA,Inc. · Aug 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626 · Synthes (Usa) · Aug 1995