Cleared Special

K991092 - EBI SPINELINK ANTERIOR CERVICAL SPINAL ...

K991092 is an FDA 510(k) clearance for EBI SPINELINK ANTERIOR CERVICAL SPINAL ..., manufactured by Electro-Biology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 28-day FDA review.

K991092 · Electro-Biology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
28d
Days
Class 2
Risk

K991092 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 Electro-Biology, Inc. (Parsippany, US). The FDA issued a Cleared decision on April 29, 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 Electro-Biology, Inc. devices

FDA 510(k) Submission Details - K991092

510(k) Number K991092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date April 29, 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.

KWQ Device Classification - Class 2, Special Controls

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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K991092.
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181 · Howmedica Osteonics Corp. · Oct 1999
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · Depuyacromed · Sep 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · Howmedica Osteonics Corp. · Jul 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · Osteonics Corp. · Mar 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · Danek Medical, Inc. · Mar 1999
XIA SPINE SYSTEM
K984251 · Howmedica, Inc. · Feb 1999