Cleared Traditional

K070891 - ALTIVA CLASSIC ACP SYSTEM

K070891 is an FDA 510(k) clearance for ALTIVA CLASSIC ACP SYSTEM, manufactured by Altiva Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K070891 · Altiva Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
73d
Days
Class 2
Risk

K070891 is an FDA 510(k) clearance for the ALTIVA CLASSIC ACP SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Altiva Corp. (Charlotte, US). The FDA issued a Cleared decision on June 11, 2007 after a review of 73 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 Altiva Corp. devices

FDA 510(k) Submission Details - K070891

510(k) Number K070891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2007
Decision Date June 11, 2007
Days to Decision 73 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 122d · This submission: 73d
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 516
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K070891.
MODIFICATION TO SPINAL USA VBR SYSTEM
K070922 · Spinal USA · Sep 2007
NUVASIVE HELIX ACP SYSTEM
K071329 · Nuvasive, Inc. · Aug 2007
GRAFT CONTAINMENT DEVICE
K070148 · Nuvasive, Inc. · Jul 2007
EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
K070994 · Depuy Spine, Inc. · 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