Cleared Traditional

K201193 - SeaSpine Spacer System NM (Hollywood

Also marketed or referenced as:
SeaSpine Vu e•POD System and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD and SeaSpine Shoreline ACS, SeaSpine Cambria System SeaSpine Regatta Lateral System and SeaSpine Meridian System, Shoreline Cervical Interbody RT System and SeaSpine Beachside System

K201193 is the FDA 510(k) clearance for SeaSpine Spacer System NM (Hollywood by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K201193 · SeaSpine Orthopedics Corporation · Orthopedic device
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Nov 2020
Decision
205d
Days
Class 2
Risk

K201193 is an FDA 510(k) clearance for the SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventur.... 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 November 25, 2020 after a review of 205 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K201193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2020
Decision Date November 25, 2020
Days to Decision 205 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
83d slower than avg
Panel avg: 122d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K201193.
Australis Anterior Lumbar Cage System
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WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
K201755 · SeaSpine Orthopedics Corporation · Dec 2020
aprevo Intervertebral Body Fusion Device
K202034 · Carlsmed, Inc. · Dec 2020
ATEC Lateral Interbody System
K202587 · Alphatec Spine, Inc. · Nov 2020
FlareHawk Interbody Fusion System
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UNiD IB3D ALIF
K200316 · Medicrea International SA · Oct 2020