Cleared Traditional

K040482 - EBI ESL SPINE SPACER SYSTEM

K040482 is the FDA 510(k) clearance for EBI ESL SPINE SPACER SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K040482 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
51d
Days
Class 2
Risk

K040482 is an FDA 510(k) clearance for the EBI ESL SPINE SPACER SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on April 16, 2004 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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, L.P. devices

Submission Details

510(k) Number K040482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2004
Decision Date April 16, 2004
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
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 - MQP Spinal Vertebral Body Replacement Device

All 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K040482.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452 · Medtronic Sofamor Danek · Jun 2004
SPINAL CONCEPTS INC. CODA
K033663 · Spinal Concepts, Inc. · May 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K040536 · Medtronic Sofamor Danek · May 2004
MODIFICATION TO GEO STRUCTURE
K040168 · Interpore Cross Intl. · Apr 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702 · Blackstone Medical, Inc. · Mar 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · Globus Medical, Inc. · Mar 2004