Cleared Traditional

K982798 - OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM

K982798 is an FDA 510(k) clearance for OSTEONICS ANTERIOR CERVICAL COMPRESSION..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K982798 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
227d
Days
Class 2
Risk

K982798 is an FDA 510(k) clearance for the OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on March 25, 1999 after a review of 227 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K982798

510(k) Number K982798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date March 25, 1999
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 622
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K982798.
WHITESIDE BIOMECHANICS SPINAL SYSTEM
K991678 · Whiteside Biomechanics, Inc. · Aug 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · Howmedica Osteonics Corp. · Jul 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · Electro-Biology, Inc. · Apr 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · Danek Medical, Inc. · Mar 1999
XIA SPINE SYSTEM
K984251 · Howmedica, Inc. · Feb 1999
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · Spinal Concepts, Inc. · Feb 1999