Cleared Traditional

K990303 - EBI OMEGA 21 SYSTEM

K990303 is an FDA 510(k) clearance for EBI OMEGA 21 SYSTEM, manufactured by Electro-Biology, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K990303 · Electro-Biology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
87d
Days
Class 2
Risk

K990303 is an FDA 510(k) clearance for the EBI OMEGA 21 SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Electro-Biology, Inc. (Parsippany, US). The FDA issued a Cleared decision on April 29, 1999 after a review of 87 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. 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 Electro-Biology, Inc. devices

FDA 510(k) Submission Details - K990303

510(k) Number K990303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date April 29, 1999
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K990303.
SYNTHES CERVIFIX SYSTEM
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OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY
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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