Cleared Traditional

K991721 - EBI OMEGA 21 SYSTEM

K991721 is an FDA 510(k) clearance for EBI OMEGA 21 SYSTEM, manufactured by Ebi Electro Biology. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K991721 · Ebi Electro Biology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
85d
Days
Class 2
Risk

K991721 is an FDA 510(k) clearance for the EBI OMEGA 21 SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Ebi Electro Biology (Parsippany, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 85 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 - K991721

510(k) Number K991721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1999
Decision Date August 13, 1999
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 234
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K991721.
EBI OMEGA 21 SYSTEM
K992333 · Electro-Biology, Inc. · Oct 1999
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K992276 · Sulzer Spine-Tech · Oct 1999
CD HORIZON SPINAL SYSTEM
K992928 · Sofamor Danek USA,Inc. · Sep 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057 · Interpore Cross Intl. · Jun 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · Synthes Spine · Mar 1999
SYNERGY D2 SPINAL IMPLANTS
K984578 · Interpore Cross Intl. · Mar 1999