Cleared Traditional

K082187 - BIOMET ANTERIOR LUMBAR PLATE

K082187 is an FDA 510(k) clearance for BIOMET ANTERIOR LUMBAR PLATE, manufactured by Ebi, L.P.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K082187 · Ebi, L.P. · Orthopedic device
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Nov 2008
Decision
101d
Days
Class 2
Risk

K082187 is an FDA 510(k) clearance for the BIOMET ANTERIOR LUMBAR PLATE. 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 November 13, 2008 after a review of 101 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, L.P. devices

FDA 510(k) Submission Details - K082187

510(k) Number K082187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2008
Decision Date November 13, 2008
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
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 612
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K082187.
ANTERIOR BUTTRESS PLATE
K081548 · Scient'X USA, Inc. · Jan 2009
APOLLO ANTERIOR CERVICAL PLATE SYSTEM
K082504 · Apollo Spine, Inc. · Jan 2009
THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
K081380 · K2m, Inc. · Nov 2008
SEEPLATE CERVICAL PLATE SYSTEM
K082037 · Amedica Corp. · Sep 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070 · Nuvasive, Inc. · Sep 2008
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K082273 · Depuy Spine, Inc. · Sep 2008