Cleared Special

K990845 - MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15

K990845 is an FDA 510(k) clearance for MODIFICATION TO PARTS NUMBERED CGT-SL A..., manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 29-day FDA review.

K990845 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Apr 1999
Decision
29d
Days
Class 2
Risk

K990845 is an FDA 510(k) clearance for the MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on April 13, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990845

510(k) Number K990845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1999
Decision Date April 13, 1999
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 424
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K990845.
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · Howmedica Osteonics Corp. · Jun 1999
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
K984375 · Osteonics Corp. · Apr 1999
EBI OMEGA 21 SYSTEM
K990303 · Electro-Biology, Inc. · Apr 1999
TITANIUM VERSALOK
K990708 · Wrightmedicaltechnologyinc · Mar 1999
CD HORIZON SPINAL SYSTEM
K981676 · Sofamor Danek USA,Inc. · Jan 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · Synthes (Usa) · Jan 1999
K990845 · MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
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