Cleared Traditional

K070148 - GRAFT CONTAINMENT DEVICE

K070148 is an FDA 510(k) clearance for GRAFT CONTAINMENT DEVICE, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K070148 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
196d
Days
Class 2
Risk

K070148 is an FDA 510(k) clearance for the GRAFT CONTAINMENT DEVICE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on July 31, 2007 after a review of 196 days - an extended review 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: 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K070148

510(k) Number K070148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2007
Decision Date July 31, 2007
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 640
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K070148.
MODIFICATION TO SPINAL USA VBR SYSTEM
K070922 · Spinal USA · Sep 2007
NUVASIVE HELIX ACP SYSTEM
K071329 · Nuvasive, Inc. · Aug 2007
C-JAWS CERVICAL COMPRESSIVE MINI FRAME
K072040 · Medicrea Technologies · Aug 2007
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