Cleared Traditional

K960107 - DDS SPINAL SYSTEM

K960107 is an FDA 510(k) clearance for DDS SPINAL SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K960107 · Encore Orthopedics, Inc. · Orthopedic device
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May 1996
Decision
113d
Days
Class 2
Risk

K960107 is an FDA 510(k) clearance for the DDS SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on May 3, 1996 after a review of 113 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K960107

510(k) Number K960107 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 11, 1996
Decision Date May 03, 1996
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 156
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K960107.
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
ISOLA TWISTER CONNECTOR
K962645 · Acromed Corp. · Oct 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · Wrightmedicaltechnologyinc · Sep 1996
WEBB-MORLEY SPINE SYSTEM
K960451 · Buckman Co., Inc. · Apr 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · Depuy, Inc. · Feb 1996
SPINE FIXATION
K943827 · Danek Medical, Inc. · Feb 1996