Cleared Special

K003384 - VERSALINK TITANIUM ROD-TO-ROD COUPLERS

K003384 is an FDA 510(k) clearance for VERSALINK TITANIUM ROD-TO-ROD COUPLERS, manufactured by Osteotech, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 24-day FDA review.

K003384 · Osteotech, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
24d
Days
Class 2
Risk

K003384 is an FDA 510(k) clearance for the VERSALINK TITANIUM ROD-TO-ROD COUPLERS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on November 24, 2000 after a review of 24 days - a notably fast clearance 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. 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 - K003384

510(k) Number K003384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2000
Decision Date November 24, 2000
Days to Decision 24 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
98d faster than avg
Panel avg: 122d · This submission: 24d
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 K003384.
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · Ebi, L.P. · Jan 2001
CD HORIZON SPINAL SYSTEM
K000641 · Medtronic Sofamor Danek, Inc. · Dec 2000
OPUS ROD FIXATION SYSTEM
K003490 · Howmedica Osteonics Corp. · Dec 2000
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
K001044 · Acme Spine, LLC · Nov 2000
GLOBAL SPINAL FIXATION SYSTEM
K001668 · D.K.M. Co., Ltd. · Oct 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · Medtronic Sofamor Danek, Inc. · Sep 2000
K003384 · VERSALINK TITANIUM ROD-TO-ROD COUPLERS
Download PDF FDA Summary Osteotech, Inc.