Cleared Traditional

K070681 - NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM

K070681 is an FDA 510(k) clearance for NEXT GENERATION ANTERIOR CERVICAL PLATI..., manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K070681 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
53d
Days
Class 2
Risk

K070681 is an FDA 510(k) clearance for the NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 4, 2007 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K070681

510(k) Number K070681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date May 04, 2007
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 620
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K070681.
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
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
K070994 · Depuy 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
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM
K070273 · Nuvasive, Inc. · Apr 2007