Cleared Special

K030581 - BLACKSTONE SPINAL FIXATION SYSTEM LATER...

K030581 is the FDA 510(k) clearance for BLACKSTONE SPINAL FIXATION SYSTEM LATER... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code MNH) cleared through the Special 510(k) pathway after a 122-day FDA review.

K030581 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
122d
Days
Class 2
Risk

K030581 is an FDA 510(k) clearance for the BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION). Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on June 26, 2003 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Blackstone Medical, Inc. devices

Submission Details

510(k) Number K030581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2003
Decision Date June 26, 2003
Days to Decision 122 days
Submission Type Special
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
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 154
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K030581.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · Medtronic Sofamor Danek, Inc. · Feb 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · Medtronic Sofamor Danek · Dec 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · Ebi, L.P. · Jun 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · Depuyacromed · Feb 2003
MONARCH SPINE SYSTEM
K024348 · Depuyacromed · Jan 2003
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · Depuyacromed · Nov 2002