Cleared Special

K993822 - EBI SPINELINK ANTERIOR CERVICAL SPINAL ...

K993822 is the FDA 510(k) clearance for EBI SPINELINK ANTERIOR CERVICAL SPINAL ... by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K993822 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
28d
Days
Class 2
Risk

K993822 is an FDA 510(k) clearance for the EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on December 10, 1999 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ebi, L.P. devices

Submission Details

510(k) Number K993822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date December 10, 1999
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K993822.
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · Depuyacromed · Dec 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · Spineology, Inc. · Dec 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · Danek Medical, Inc. · Dec 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · Howmedica Osteonics Corp. · Nov 1999
NEXT GENERATION RODDING SYSTEM
K992784 · United States Surgical, A Division of Tyco Healthc · Oct 1999
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181 · Howmedica Osteonics Corp. · Oct 1999