Cleared Traditional

K946348 - TITANIUM TSRH SPINAL SYSTEM (SCREWS)

K946348 is an FDA 510(k) clearance for TITANIUM TSRH SPINAL SYSTEM (SCREWS), manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K946348 · Sofamor Danek USA,Inc. · Orthopedic device
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Aug 1995
Decision
220d
Days
Class 2
Risk

K946348 is an FDA 510(k) clearance for the TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS). Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 220 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K946348

510(k) Number K946348 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 30, 1994
Decision Date August 07, 1995
Days to Decision 220 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
98d slower than avg
Panel avg: 122d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K946348.
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · Synthes (Usa) · Aug 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074 · Wrightmedicaltechnologyinc · Aug 1995
ACROMED PEDICLE SCREW
K951116 · Acromed Corp. · Aug 1995
ISOLA SPINE SYSTEM
K944737 · Acromed Corp. · Jun 1995
SIMMONS PLATING SYSTEM BOLT AND SCREW
K930353 · Smith & Nephew, Inc. · Jun 1995
ROGOZINSKI SPINAL ROD SYSTEM SCREW
K930298 · Smith & Nephew Richards, Inc. · Jun 1995