Cleared Traditional

K181531 - SpineEX Sagittae Lateral Lumbar Interbo...

K181531 is the FDA 510(k) clearance for SpineEX Sagittae Lateral Lumbar Interbo... by Spineex, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K181531 · Spineex, Inc. · Orthopedic device
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Oct 2018
Decision
116d
Days
Class 2
Risk

K181531 is an FDA 510(k) clearance for the SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices. 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 Spineex, Inc. (Fremont, US). The FDA issued a Cleared decision on October 5, 2018 after a review of 116 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 Spineex, Inc. devices

Submission Details

510(k) Number K181531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2018
Decision Date October 05, 2018
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 Consultant

Empirical Testing Corp
Meredith Lee May

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 576
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181531.
Spinal Elements Ti-Bond coated devices
K181837 · Spinal Elements, Inc. · Nov 2018
Duo Lumbar Interbody Fusion Device
K182322 · Spineology, Inc. · Oct 2018
EIT Cellular Titanium® Lumbar Cage LLIF
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DualX
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