Cleared Traditional

K082310 - HOLLYWOOD, PACIFICA, REDONDO, VENTURA

K082310 is an FDA 510(k) clearance for HOLLYWOOD, manufactured by Seaspine, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K082310 · Seaspine, Inc. · Orthopedic device
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Nov 2008
Decision
89d
Days
Class 2
Risk

K082310 is an FDA 510(k) clearance for the HOLLYWOOD, PACIFICA, REDONDO, VENTURA. 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, Inc. (Vista, US). The FDA issued a Cleared decision on November 10, 2008 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seaspine, Inc. devices

FDA 510(k) Submission Details - K082310

510(k) Number K082310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2008
Decision Date November 10, 2008
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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 891
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K082310.
CLYDESDALE SPINAL SYSTEM
K083026 · Medtronic Sofamor Danek · Dec 2008
DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
K081673 · Ionics Medical Corp. · Nov 2008
DEPUY SPINE LATERAL CAGE SYSTEM
K082128 · Depuy Spine · Nov 2008
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K082774 · Lanx, LLC · Oct 2008
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
K082260 · Calvary Spine, LLC · Oct 2008
SPINAL USA VBR SYSTEM
K081196 · Spinal USA · Oct 2008