Cleared Traditional

Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage (K173800) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173800 · Camber Spine Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
50d
Days
Class 2
Risk

K173800 is an FDA 510(k) clearance for the Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Camber Spine Technologies (Wayne, US). The FDA issued a Cleared decision on February 2, 2018 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Camber Spine Technologies devices

Submission Details

510(k) Number K173800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2017
Decision Date February 02, 2018
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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

Musculoskeletal Clinical Regulatory Advisers, LLC
Justin Eggleton

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 - MQP Spinal Vertebral Body Replacement Device

All 70
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K173800.
FORTIFY Corpectomy Spacers
K173982 · Globus Medical, Inc. · Sep 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · Medtronic Sofamor Danek USA, Inc. · Sep 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
K173787 · Medos International SARL · Jun 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · Medtronic Sofamor Danek · Dec 2017
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
NuVasive(r) Monolith Corpectomy System
K170271 · Nu Vasive, Incorporated · Mar 2017