Cleared Traditional

K170503 - EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages

K170503 is an FDA 510(k) clearance for EIT Cellular Titanium Cervical Cage, manufactured by Eit Emerging Implant Technologies GmbH. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K170503 · Eit Emerging Implant Technologies GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
140d
Days
Class 2
Risk

K170503 is an FDA 510(k) clearance for the EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Ce.... 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 July 11, 2017 after a review of 140 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 Eit Emerging Implant Technologies GmbH devices

FDA 510(k) Submission Details - K170503

510(k) Number K170503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date July 11, 2017
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 Consultant

Musculoskeletal Clinical Regulatory Advisers, LLC
Justin Eggleton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K170503.
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CRESCENT™ Spinal System
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SAGICO IBF SYSTEM – ARIA LUMBAR, SAGICO IBF SYSTEM – ARION CERVICAL
K161710 · Spinal Analytics & Geometrical Impant Co, LLC · Jun 2017