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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K070530.
DVX SPINE SYSTEM
K080876 · Bk Meditech, Co., Ltd. · Jun 2008
ACCIN PEDICLE SCREW SYSTEM
K073531 · Accelerated Innovation, LLC · Feb 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
LOWTOP PEDICLE SCREW SYSTEM
K070933 · Sanacor · Jun 2007
VERTIFLEX SPINAL SCREW SYSTEM
K062670 · Vertiflex (Tm), Incorporated · Jan 2007
K070530 · MODIFICATION TO PASSMED SPINAL SYSTEM
Download PDF FDA Summary Medicrea Technologies