Cleared Traditional

K962608 - SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR

K962608 is an FDA 510(k) clearance for SYNTHES (U.S.A.) UNIVERSAL SPINAL PARAL..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K962608 · Synthes (Usa) · Orthopedic device
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Dec 1996
Decision
159d
Days
Class 2
Risk

K962608 is an FDA 510(k) clearance for the SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR. 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 December 9, 1996 after a review of 159 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K962608

510(k) Number K962608 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 03, 1996
Decision Date December 09, 1996
Days to Decision 159 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
37d slower than avg
Panel avg: 122d · This submission: 159d
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 273
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K962608.
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
K950099 · Buckman Co., Inc. · Jan 1997
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
K963357 · Synthes (Usa) · Jan 1997
ACROMED CABLE/WIRE PEDICLE SCREW
K964007 · Acromed Corp. · Dec 1996
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