Cleared Traditional

K081730 - NOVEL CERVICAL SPINAL SPACER SYSTEM

K081730 is an FDA 510(k) clearance for NOVEL CERVICAL SPINAL SPACER SYSTEM, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K081730 · Alphatec Spine, Inc. · Orthopedic device
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Sep 2008
Decision
93d
Days
Class 2
Risk

K081730 is an FDA 510(k) clearance for the NOVEL CERVICAL SPINAL SPACER SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 19, 2008 after a review of 93 days - within the typical 510(k) review window.

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 Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K081730

510(k) Number K081730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date September 19, 2008
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, 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.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 343
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K081730.
PHANTOM PLUS CAGE SYSTEM
K082801 · Us Spine · Dec 2008
NUVASIVE COROENT SYSTEM
K081611 · Nuvasive, Inc. · Oct 2008
ATLAS SPINE SPACER
K081880 · Atlas Spine, Inc. · Oct 2008
ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
K081614 · Interbody Innovations, Llp · Sep 2008
CIMPLICITY SPINAL SYSTEM
K073320 · Spine Smith Partners L.P. · Feb 2008
CRYSTAL
K073351 · Spinal Elements, Inc. · Jan 2008