Cleared Traditional

K981008 - SIMAL CERVICAL STABILIZATION SYSTEM

K981008 is an FDA 510(k) clearance for SIMAL CERVICAL STABILIZATION SYSTEM, manufactured by Top Surgical Products GmbH. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K981008 · Top Surgical Products GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
70d
Days
Class 2
Risk

K981008 is an FDA 510(k) clearance for the SIMAL CERVICAL STABILIZATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Top Surgical Products GmbH (Jeffrey, US). The FDA issued a Cleared decision on May 27, 1998 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Top Surgical Products GmbH devices

FDA 510(k) Submission Details - K981008

510(k) Number K981008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1998
Decision Date May 27, 1998
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
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 511
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K981008.
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · United States Surgical, A Division of Tyco Healthc · Dec 1998
DOC VENTRAL CERVICAL STABILIZATION SYSTEM
K982443 · Depuy Motech Acromed · Jul 1998
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
K974885 · Blackstone Medical, Inc. · Jun 1998
UNIVERSITY PLATE ANTERIOR SYSTEM
K980228 · Acromed Corp. · Apr 1998
ORION ANTERIOR CERVICAL PLATE SYSTEM
K973854 · Sofamor Danek USA,Inc. · Mar 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706 · Aesculap, Inc. · Mar 1998