Cleared Traditional

K982322 - SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM

K982322 is an FDA 510(k) clearance for SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K982322 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 1998
Decision
146d
Days
Class 2
Risk

K982322 is an FDA 510(k) clearance for the SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on November 25, 1998 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K982322

510(k) Number K982322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1998
Decision Date November 25, 1998
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 376
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K982322.
SCS SPINAL SYSTEM
K983353 · Orthotec, Inc. · Dec 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K983530 · Synthes (Usa) · Dec 1998
DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
K983583 · Depuy, Inc. · Dec 1998
OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
K983282 · Ohio Medical Instrument Co., Inc. · Nov 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K983706 · Sofamor Danek USA,Inc. · Nov 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)
K983197 · United States Surgical, A Division of Tyco Healthc · Oct 1998