Cleared Traditional

K042930 - SPACEVISION CAGE SYSTEM

K042930 is an FDA 510(k) clearance for SPACEVISION CAGE SYSTEM, manufactured by Spine Vision, Inc.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K042930 · Spine Vision, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
67d
Days
Class 2
Risk

K042930 is an FDA 510(k) clearance for the SPACEVISION CAGE SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spine Vision, Inc. (Atlanta, US). The FDA issued a Cleared decision on December 28, 2004 after a review of 67 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.

FDA 510(k) Submission Details - K042930

510(k) Number K042930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2004
Decision Date December 28, 2004
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

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 Peers - MQP Spinal Vertebral Body Replacement Device

All 278
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K042930.
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
K042713 · Spine Next America Corporation · Dec 2004
FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 4
K042714 · Spine Next America Corporation · Dec 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · Medtronic Sofamor Danek · Dec 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · Ebi, L.P. · Oct 2004
NOVEL VBR SPINAL SYSTEM
K042201 · Alphatec/Nexmed · Oct 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · Synthes Spine · Oct 2004
K042930 · SPACEVISION CAGE SYSTEM
Download PDF FDA Summary Spine Vision, Inc.