Cleared Traditional

K172888 - EIT Cellular Titanium Cervical Cages

K172888 is the FDA 510(k) clearance for EIT Cellular Titanium Cervical Cages 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 85-day FDA review.

K172888 · Eit Emerging Implant Technologies GmbH · Orthopedic device
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Dec 2017
Decision
85d
Days
Class 2
Risk

K172888 is an FDA 510(k) clearance for the EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT.... 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 December 15, 2017 after a review of 85 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 K172888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date December 15, 2017
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 596
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Juliet Ti LL
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