Cleared Traditional

K982798 - OSTEONICS ANTERIOR CERVICAL COMPRESSION...

K982798 is the FDA 510(k) clearance for OSTEONICS ANTERIOR CERVICAL COMPRESSION... by Osteonics Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 443
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K982798.
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · Depuyacromed · Sep 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