Cleared Traditional

K963357 - MODIFICATION TO THE SYNTHES (USA) UNIVE...

K963357 is the FDA 510(k) clearance for MODIFICATION TO THE SYNTHES (USA) UNIVE... by Synthes (Usa). It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K963357 · Synthes (Usa) · Orthopedic device
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Jan 1997
Decision
136d
Days
Class 2
Risk

K963357 is an FDA 510(k) clearance for the MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL .... Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on January 9, 1997 after a review of 136 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 Synthes (Usa) devices

Submission Details

510(k) Number K963357 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 26, 1996
Decision Date January 09, 1997
Days to Decision 136 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
14d slower than avg
Panel avg: 122d · This submission: 136d
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 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K963357.
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964544 · Osteonics Corp. · Feb 1997
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
K964304 · Osteonics Corp. · Jan 1997
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K950099 · Buckman Co., Inc. · Jan 1997
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · Acromed Corp. · Dec 1996
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
ISOLA TWISTER CONNECTOR
K962645 · Acromed Corp. · Oct 1996