Cleared Traditional

K984027 - EBI SPINELINK SYSTEM

K984027 is an FDA 510(k) clearance for EBI SPINELINK SYSTEM, manufactured by Electro-Biology, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K984027 · Electro-Biology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
68d
Days
Class 2
Risk

K984027 is an FDA 510(k) clearance for the EBI SPINELINK SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Electro-Biology, Inc. (Parsippany, US). The FDA issued a Cleared decision on January 19, 1999 after a review of 68 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 Electro-Biology, Inc. devices

FDA 510(k) Submission Details - K984027

510(k) Number K984027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date January 19, 1999
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K984027.
SYNERGY D2 SPINAL IMPLANTS
K984578 · Interpore Cross Intl. · Mar 1999
OSTEONICS COMBINATION SCREW RING/BLOCKER
K990158 · Osteonics Corp. · Feb 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059 · Howmedica Osteonics Corp. · Jan 1999
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
K984612 · Synthes Spine · Jan 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · Danek Medical, Inc. · Jan 1999
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · Depuy, Inc. · Dec 1998