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
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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.

View all Disc-O-Tech Medical Technologies, Ltd. devices

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 56
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K063067.
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
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ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · Medtronic Sofamor Danek · Mar 2007
CONFIDENCE EX HIGH VISCOSITY BONE CEMENT
K062424 · Disc-O-Tech Medical Technologies, Ltd. · Sep 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA
K060425 · Arthrocare Corp. · Jul 2006
STAXX FX SYSTEM
K053336 · Spine Wave, Inc. · Jul 2006