Cleared Traditional

K961572 - VERSALOK SCREW ASSEMBLY (PROPOSED NAME)

K961572 is an FDA 510(k) clearance for VERSALOK SCREW ASSEMBLY (PROPOSED NAME), manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K961572 · Wrightmedicaltechnologyinc · Orthopedic device
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Sep 1996
Decision
147d
Days
Class 2
Risk

K961572 is an FDA 510(k) clearance for the VERSALOK SCREW ASSEMBLY (PROPOSED NAME). Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on September 17, 1996 after a review of 147 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K961572

510(k) Number K961572 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 23, 1996
Decision Date September 17, 1996
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 280
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K961572.
ISOLA TWISTER CONNECTOR
K962645 · Acromed Corp. · Oct 1996
ULTIUM SPINAL PLATING SYSTEM
K962784 · Smith & Nephew, Inc., Orthopaedic Div. · Oct 1996
J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
K962757 · J.B.S., S.A. · Sep 1996
DDS SPINAL SYSTEM
K960107 · Encore Orthopedics, Inc. · May 1996
WEBB-MORLEY SPINE SYSTEM
K960451 · Buckman Co., Inc. · Apr 1996
SPINE SYSTEM SACRAL PLATE
K953881 · J.B.S., S.A. · Feb 1996