Cleared Traditional

K081880 - ATLAS SPINE SPACER

K081880 is an FDA 510(k) clearance for ATLAS SPINE SPACER, manufactured by Atlas Spine, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K081880 · Atlas Spine, Inc. · Orthopedic device
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Oct 2008
Decision
92d
Days
Class 2
Risk

K081880 is an FDA 510(k) clearance for the ATLAS SPINE SPACER. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 92 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 Atlas Spine, Inc. devices

FDA 510(k) Submission Details - K081880

510(k) Number K081880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2008
Decision Date October 02, 2008
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 243
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K081880.
CALIX SPINAL IMPLANT SYSTEM
K083637 · X-Spine Systems, Inc. · Apr 2009
CAMBRIA
K082309 · Seaspine, Inc. · Apr 2009
NUVASIVE COROENT SYSTEM
K081611 · Nuvasive, Inc. · Oct 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730 · Alphatec Spine, Inc. · Sep 2008
CRYSTAL
K073351 · Spinal Elements, Inc. · Jan 2008
PATRIOT SPACERS: COLONIAL ACDF
K072991 · Globus Medical, Inc. · Jan 2008