Cleared Traditional

K192132 - SeaSpine Beachside System

K192132 is the FDA 510(k) clearance for SeaSpine Beachside System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K192132 · SeaSpine Orthopedics Corporation · Orthopedic device
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Dec 2019
Decision
118d
Days
Class 2
Risk

K192132 is an FDA 510(k) clearance for the SeaSpine Beachside System. 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 December 3, 2019 after a review of 118 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K192132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2019
Decision Date December 03, 2019
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 K192132.
Keos Lumbar IBFD
K193174 · Keos · Dec 2019
Neo Cage System
K191796 · Neo Medical SA · Dec 2019
Genesys Spine 3DP Lumbar Interbody System
K182987 · Genesys Spine · Dec 2019
Peridot Intervertebral body fusion System
K192026 · Gbs Commonwealth Co., Ltd. · Nov 2019
Cortina™ [MAX] Lumbar Cage System
K192248 · Neurostructures, Inc. · Nov 2019
LongBow Ti
K190721 · Life Spine, Inc. · Nov 2019