Cleared Traditional

K192208 - CORNICE Cervical Spacer System

K192208 is the FDA 510(k) clearance for CORNICE Cervical Spacer System by Legend Spine Technologies. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K192208 · Legend Spine Technologies · Orthopedic device
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Oct 2019
Decision
56d
Days
Class 2
Risk

K192208 is an FDA 510(k) clearance for the CORNICE Cervical Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Legend Spine Technologies (Bethlehem, US). The FDA issued a Cleared decision on October 9, 2019 after a review of 56 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 Legend Spine Technologies devices

Submission Details

510(k) Number K192208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2019
Decision Date October 09, 2019
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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

Mrc-X, LLC
Christine Scifert

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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 215
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K192208.
ADI Cervical Interbody Fusion Device
K191812 · Additive Device, Inc. (Adi) D/B/A Restor3D · Oct 2019
Matrix HA PEEK Cervical Implant System
K192316 · Sapphire Medical Group · Oct 2019
Nano FortiCore, FortiCore
K191822 · Nanovis, LLC · Oct 2019
eCarbon IBDs
K191537 · Back 2 Basics Direct, LLC · Sep 2019
HEDRON Cervical Spacers
K191243 · Globus Medical, Inc. · Sep 2019
Ti3Z Cervical Interbody System
K191354 · Zavation Medical Products, LLC · Sep 2019