Cleared Traditional

K183447 - EIT Cellular Titanium Lumbar Cage - T/PLIF

K183447 is the FDA 510(k) clearance for EIT Cellular Titanium Lumbar Cage - T/PLIF by Eit Emerging Implant Technologies GmbH. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K183447 · Eit Emerging Implant Technologies GmbH · Orthopedic device
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Feb 2019
Decision
54d
Days
Class 2
Risk

K183447 is an FDA 510(k) clearance for the EIT Cellular Titanium Lumbar Cage - T/PLIF. 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 Eit Emerging Implant Technologies GmbH (Wurmlingen, DE). The FDA issued a Cleared decision on February 4, 2019 after a review of 54 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 Eit Emerging Implant Technologies GmbH devices

Submission Details

510(k) Number K183447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2018
Decision Date February 04, 2019
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
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 595
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K183447.
Altus Spine Interbody Fusion System
K182406 · Altus Partners, LLC · Feb 2019
Reliance Lumbar IBF System
K183049 · Reliance Medical Systems, LLC · Feb 2019
Omnia Medical Rotary PLIF System
K183659 · Omnia Medical, LLC · Feb 2019
Neo Cage System TM
K181048 · Neo Medical SA · Jan 2019
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
K180822 · Wenzel Spine, Inc. · Jan 2019
NEST Interbody System
K180230 · Paonan Biotech Co., Ltd. · Jan 2019