Cleared Special

K063067 - CONFIDENCE FENESTRATED INTRODUCER NEEDLE

K063067 is an FDA 510(k) clearance for CONFIDENCE FENESTRATED INTRODUCER NEEDLE, manufactured by Disc-O-Tech Medical Technologies, Ltd.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 28-day FDA review.

K063067 · Disc-O-Tech Medical Technologies, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
28d
Days
Class 2
Risk

K063067 is an FDA 510(k) clearance for the CONFIDENCE FENESTRATED INTRODUCER NEEDLE. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Disc-O-Tech Medical Technologies, Ltd. (Washington, US). The FDA issued a Cleared decision on November 3, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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. Low regulatory complexity profile. 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 - K063067

510(k) Number K063067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2006
Decision Date November 03, 2006
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K063067.
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · Medtronic Sofamor Danek · May 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · Medtronic Sofamor Danek · Mar 2007
VSPSPN
K063438 · Tecres S.P.A. · Jan 2007
KIT MENDEC SPINE AND DELIVERY SYSTEM
K062452 · Tecres S.P.A. · Sep 2006
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424 · Disc-O-Tech Medical Technologies, Ltd. · Sep 2006
SPACE CPSXL BONE CEMENT
K061531 · Dfine, Inc. · Aug 2006
K063067 · CONFIDENCE FENESTRATED INTRODUCER NEEDLE
Download PDF FDA Summary Disc-O-Tech Medical T…