Cleared Special

K070994 - EAGLE + ANTERIOR CERVICAL PLATE SYSTEM

K070994 is an FDA 510(k) clearance for EAGLE + ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K070994 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
30d
Days
Class 2
Risk

K070994 is an FDA 510(k) clearance for the EAGLE + ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on May 9, 2007 after a review of 30 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.

FDA 510(k) Submission Details - K070994

510(k) Number K070994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2007
Decision Date May 09, 2007
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 664
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K070994.
ALTIVA CLASSIC ACP SYSTEM
K070891 · Altiva Corp. · Jun 2007
OSSTAPLE, OSSPLATE, OSSFORCE
K061385 · Biomedical Enterprises, Inc. · May 2007
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM
K063764 · Southern Spine, LLC · May 2007
NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
K070681 · Alphatec Spine, Inc. · May 2007
MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
K070775 · Globus Medical, Inc. · Apr 2007
SIMPLEX CERVICAL FIXATION SYSTEM
K070335 · Pisharodi Surgicals, Inc. · Apr 2007
K070994 · EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
Download PDF FDA Summary Depuy Spine, Inc.