Cleared Traditional

K991036 - DANEK PLATE AND SCREW SYSTEM

K991036 is an FDA 510(k) clearance for DANEK PLATE AND SCREW SYSTEM, 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 169-day FDA review.

K991036 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
169d
Days
Class 2
Risk

K991036 is an FDA 510(k) clearance for the DANEK PLATE AND SCREW SYSTEM. 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 September 14, 1999 after a review of 169 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 - K991036

510(k) Number K991036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date September 14, 1999
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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 K991036.
CD HORIZON SPINAL SYSTEM
K993810 · Danek Medical, Inc. · Feb 2000
SOCON SPINAL SYSTEM
K993551 · Aesculap, Inc. · Jan 2000
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
K993808 · Interpore Cross Intl. · Dec 1999
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · Howmedica Osteonics Corp. · Aug 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · Synthes (Usa) · Jun 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · Danek Medical, Inc. · May 1999