Cleared Special

K070276 - MODIFICATION TO PASSMED SPINAL SYSTEM

K070276 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 MNI cleared through the Special 510(k) pathway after a 235-day FDA review.

K070276 · Medicrea Technologies · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
235d
Days
Class 2
Risk

K070276 is an FDA 510(k) clearance for the MODIFICATION TO PASSMED SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Medicrea Technologies (Round Rock, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 235 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 - K070276

510(k) Number K070276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date September 21, 2007
Days to Decision 235 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
113d slower than avg
Panel avg: 122d · This submission: 235d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K070276.
MEGA SPINE SYSTEM
K072436 · Bk Meditech, Co., Ltd. · Nov 2007
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
LANX SPINAL FIXATION SYSTEM
K071877 · Lanx, LLC · Sep 2007
ACME TALON PEDICLE SCREW
K071824 · Acme Spine, LLC · Sep 2007
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K063453 · Elite Surgical Supplies (Pty), Ltd. · Aug 2007
K070276 · MODIFICATION TO PASSMED SPINAL SYSTEM
Download PDF FDA Summary Medicrea Technologies