Cleared Traditional

K190895 - MOUNTAINEER OCT Spinal System

K190895 is the FDA 510(k) clearance for MOUNTAINEER OCT Spinal System by Medos International SARL. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K190895 · Medos International SARL · Orthopedic device
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Jul 2019
Decision
104d
Days
Class 2
Risk

K190895 is an FDA 510(k) clearance for the MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY.... Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on July 18, 2019 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 Medos International SARL devices

Submission Details

510(k) Number K190895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2019
Decision Date July 18, 2019
Days to Decision 104 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 faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of Fusion.
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 Synthes Spine
Sheree Geller

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 - NKG Posterior Cervical Screw System

All 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K190895.
SYPMHONY™ OCT System
K192014 · Medos International SARL · Jan 2020
Innovasis Gibralt Spine System
K192354 · Innovasis, Inc. · Sep 2019
NuVaisve® Reline® Cervical System
K191553 · Nu Vasive, Incorporated · Aug 2019
Solanas® Posterior OCT Fixation System
K191185 · Alphatec Spine · Jun 2019
Connector System
K190751 · Orthofix, Inc. · May 2019
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · Medacta International S.A. · Apr 2019