Cleared Traditional

K153782 - NuVasive® Lumbar Interbody Implants

K153782 is an FDA 510(k) clearance for NuVasive Lumbar Interbody Implants, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K153782 · Nu Vasive, Incorporated · Orthopedic device
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Mar 2016
Decision
84d
Days
Class 2
Risk

K153782 is an FDA 510(k) clearance for the NuVasive® Lumbar Interbody Implants. 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 Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on March 24, 2016 after a review of 84 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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K153782

510(k) Number K153782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2015
Decision Date March 24, 2016
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
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 853
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153782.
Opticage(R) Expandable Interbody Fusion Device
K160464 · Interventional Spine, Inc. · Apr 2016
Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System
K153495 · Ldr Spine USA · Mar 2016
SurgTech Interbody System
K152200 · Surgtech, Inc. · Mar 2016
Cascadia Interbody System
K160547 · K2m · Mar 2016
NuVasive® TLX Interbody System
K153627 · Nu Vasive, Incorporated · Mar 2016
SUSTAIN Additional Implants
K151665 · Globus Medical, Inc. · Mar 2016