Cleared Traditional

K171046 - SeaSpine Cambria System

K171046 is the FDA 510(k) clearance for SeaSpine Cambria System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K171046 · SeaSpine Orthopedics Corporation · Orthopedic device
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Jul 2017
Decision
91d
Days
Class 2
Risk

K171046 is an FDA 510(k) clearance for the SeaSpine Cambria System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on July 7, 2017 after a review of 91 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K171046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2017
Decision Date July 07, 2017
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K171046.
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
K172587 · Medacta International S.A. · Sep 2017
Tritanium C Anterior Cervical Cage
K171496 · Stryker Spine · Sep 2017
Calix-C Cervical Interbody Spacer
K171075 · X-Spine Systems, Inc. · Aug 2017
Foundation 3D Interbody
K162496 · Corelink, LLC · May 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017
The Small PLATEAU (PLATEAU-C) Spacer System
K161127 · Life Spine, Inc. · Dec 2016