Cleared Special

K151352 - CONCORDE Bullet Spinal System

K151352 is the FDA 510(k) clearance for CONCORDE Bullet Spinal System by Medos International SARL. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 141-day FDA review.

K151352 · Medos International SARL · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
141d
Days
Class 2
Risk

K151352 is an FDA 510(k) clearance for the CONCORDE Bullet Spinal System. 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 Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on October 8, 2015 after a review of 141 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medos International SARL devices

Submission Details

510(k) Number K151352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2015
Decision Date October 08, 2015
Days to Decision 141 days
Submission Type Special
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
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Modification to existing cleared device.

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

Depuy Spine, A Johnson & Johnson Company
JEFFREY SHIFFMAN

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 609
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151352.
Tritanium PL Cage
K152304 · Stryker · Nov 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Px HA PEEK IBF System
K151785 · Innovasis, Inc. · Oct 2015
LOSPA IS Spinal System
K151408 · Corentec Co., Ltd. · Oct 2015
NuVasive CoRoent Lumbar System
K151472 · Nu Vasive, Incorporated · Sep 2015
Cascadia Interbody System
K150481 · K2m, Inc. · Aug 2015