Cleared Traditional

K973923 - EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

K973923 is an FDA 510(k) clearance for EBI SPINELINK ANTERIOR CERVICAL SPINAL ..., manufactured by Ebi Electro Biology. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973923 · Ebi Electro Biology · Orthopedic device
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Jan 1998
Decision
90d
Days
Class 2
Risk

K973923 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 Electro Biology (Parsippany, US). The FDA issued a Cleared decision on January 13, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ebi Electro Biology devices

FDA 510(k) Submission Details - K973923

510(k) Number K973923 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 15, 1997
Decision Date January 13, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 559
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K973923.
KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS
K974757 · Acromed Corp. · Mar 1998
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
K974525 · Synthes Spine · Mar 1998
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
K974435 · Wrightmedicaltechnologyinc · Feb 1998
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730 · Depuy, Inc. · Nov 1997
DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM
K973060 · Depuy, Inc. · Nov 1997
SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K971883 · Synthes (Usa) · Oct 1997