Cleared Traditional

K012516 - EBI SPINELINK - II SPINAL FIXATION SYSTEM

K012516 is an FDA 510(k) clearance for EBI SPINELINK - II SPINAL FIXATION SYSTEM, manufactured by Ebi, L.P.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K012516 · Ebi, L.P. · Orthopedic device
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Nov 2001
Decision
113d
Days
Class 2
Risk

K012516 is an FDA 510(k) clearance for the EBI SPINELINK - II SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on November 27, 2001 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K012516

510(k) Number K012516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date November 27, 2001
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K012516.
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · Medtronic Sofamor Danek, Inc. · Jan 2002
PASS SPINAL SYSTEM
K013442 · Encore Orthopedics, Inc. · Jan 2002
XIA SPINAL SYSTEM
K013823 · Howmedica Osteonics Corp. · Dec 2001
ISOLA POLYAXIAL WASHER
K013441 · Depuyacromed · Nov 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · Medtronic Sofamor Danek, Inc. · Sep 2001
XIA STAINLESS STEEL SYSTEM
K012870 · Howmedica Osteonics Corp. · Sep 2001