Cleared Abbreviated

K990959 - K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM

K990959 is an FDA 510(k) clearance for K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Abbreviated 510(k) pathway after a 280-day FDA review.

K990959 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
280d
Days
Class 2
Risk

K990959 is an FDA 510(k) clearance for the K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spineology, Inc. (Stillwater, US). The FDA issued a Cleared decision on December 27, 1999 after a review of 280 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spineology, Inc. devices

FDA 510(k) Submission Details - K990959

510(k) Number K990959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date December 27, 1999
Days to Decision 280 days
Submission Type Abbreviated
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
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Standards-based clearance path.

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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K990959.
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BONE GRAFT WASHER, MODEL 9090114 - 9090118
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MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · Depuyacromed · Dec 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · Danek Medical, Inc. · Dec 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K993822 · Ebi, L.P. · Dec 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · Howmedica Osteonics Corp. · Nov 1999