Cleared Traditional

K973683 - OMEGA 21 SYSTEM

K973683 is an FDA 510(k) clearance for OMEGA 21 SYSTEM, manufactured by Ebi Electro Biology. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K973683 · Ebi Electro Biology · Orthopedic device
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Dec 1997
Decision
89d
Days
Class 2
Risk

K973683 is an FDA 510(k) clearance for the OMEGA 21 SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ebi Electro Biology (Parsippany, US). The FDA issued a Cleared decision on December 24, 1997 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Ebi Electro Biology devices

FDA 510(k) Submission Details - K973683

510(k) Number K973683 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 26, 1997
Decision Date December 24, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 238
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K973683.
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
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K974213 · United States Surgical, A Division of Tyco Healthc · Feb 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K972568 · Depuy, Inc. · Sep 1997
EBI SPINELINK SYSTEM
K971970 · Electro-Biology, Inc. · Aug 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285 · Aesculap, Inc. · Jun 1997