Cleared Special

K070530 - MODIFICATION TO PASSMED SPINAL SYSTEM

K070530 is an FDA 510(k) clearance for MODIFICATION TO PASSMED SPINAL SYSTEM, manufactured by Medicrea Technologies. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 237-day FDA review.

K070530 · Medicrea Technologies · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
237d
Days
Class 2
Risk

K070530 is an FDA 510(k) clearance for the MODIFICATION TO PASSMED SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Medicrea Technologies (Round Rock, US). The FDA issued a Cleared decision on October 18, 2007 after a review of 237 days - an extended review cycle.

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 Medicrea Technologies devices

FDA 510(k) Submission Details - K070530

510(k) Number K070530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date October 18, 2007
Days to Decision 237 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 122d · This submission: 237d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

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 197
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K070530.
MOUNTAINEER OCT SPINAL SYSTEM
K080828 · Depuy Spine, Inc. · Jun 2008
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS
K081381 · K2m, Inc. · Jun 2008
ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM
K071890 · Alphatec Spine, Inc. · Nov 2007
CAPLESS LI PEDICLE SCREW SYSTEM
K072282 · X-Spine Systems, Inc. · Sep 2007
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K062174 · Depuy Spine, Inc. · Nov 2006
ISS INTEGRATED SPINE SYSTEM
K061524 · Ortho Development Corp. · Sep 2006