Cleared Traditional

K982006 - MICOMED - HALM ZIELKE INSTRUMENTATION

K982006 is an FDA 510(k) clearance for MICOMED - HALM ZIELKE INSTRUMENTATION, manufactured by Micomed GmbH. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K982006 · Micomed GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 1999
Decision
226d
Days
Class 2
Risk

K982006 is an FDA 510(k) clearance for the MICOMED - HALM ZIELKE INSTRUMENTATION. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Micomed GmbH (Fullerton, US). The FDA issued a Cleared decision on January 20, 1999 after a review of 226 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 Micomed GmbH devices

FDA 510(k) Submission Details - K982006

510(k) Number K982006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date January 20, 1999
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
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 K982006.
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
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · Danek Medical, Inc. · Jan 1999
BODYFORM THORACO-LUMBAR FIXATION SYSTEM
K983622 · Theken Surgical,Llc · Dec 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · United States Surgical, A Division of Tyco Healthc · Dec 1998