Cleared Special

K162715 - SeaSpine Spacer System- Hollywood NanoM...

Also marketed or referenced as:
SeaSpine Cambria NanoMetalene

K162715 is the FDA 510(k) clearance for SeaSpine Spacer System- Hollywood NanoM... by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K162715 · SeaSpine Orthopedics Corporation · Orthopedic device
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Oct 2016
Decision
29d
Days
Class 2
Risk

K162715 is an FDA 510(k) clearance for the SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ve.... Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on October 28, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K162715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2016
Decision Date October 28, 2016
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K162715.
Xsert Lumbar Expandable Interbody System
K160959 · X-Spine Systems, Inc. · Nov 2016
Tritanium® PL Cage
K162262 · Stryker · Nov 2016
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
K162358 · Synthes USA Products, LLC · Nov 2016
Rampart D Lumbar Interbody Fusion Device
K160074 · Spineology, Inc. · Oct 2016
Cascadia Interbody System
K162264 · K2m, Inc. · Sep 2016
JULIET® LL Lateral Lumbar Cage
K161888 · Spineart · Sep 2016