Cleared Traditional

K102606 - AVS ANCHOR-C CERVICAL CAGE SYSTEM

K102606 is the FDA 510(k) clearance for AVS ANCHOR-C CERVICAL CAGE SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K102606 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
224d
Days
Class 2
Risk

K102606 is an FDA 510(k) clearance for the AVS ANCHOR-C CERVICAL CAGE SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on April 22, 2011 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Stryker Spine devices

Submission Details

510(k) Number K102606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date April 22, 2011
Days to Decision 224 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
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 115
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K102606.
PRO-LINK CERVICAL SPACER SYSTEM
K121151 · Life Spine, Inc. · Nov 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · Medtronic Sofamor Danek · Jan 2012
CHESAPEAKE (CERVICAL COMPONENTS)
K111439 · K2m, Inc. · Aug 2011
COROENT INTERLOCK SYSTEM
K102547 · Nuvasive, Inc. · Feb 2011
SYNTHES ZERO-P
K093762 · Synthes Spine · Dec 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · Medtronic Sofamor Danek · Jun 2010