Cleared Special

K101762 - VIPER F2 FACET FIXATION SYSTEM

K101762 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
146d
Days
-
Risk

K101762 is an FDA 510(k) clearance for the VIPER F2 FACET FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on November 15, 2010 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. 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.

View all Depuy Spine, Inc. devices

FDA 510(k) Submission Details - K101762

510(k) Number K101762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2010
Decision Date November 15, 2010
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

MRW Device Classification - Class 0,

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 65
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K101762.
SPARTAN S3 FACET SYSTEM
K113011 · Amendia, Inc. · Dec 2011
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc. · Nov 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
PRIMALOK FACET FIXATION SYSTEM
K102438 · Osteomed LP · Sep 2010
LANX FACET SCREW SYSTEM
K101364 · Lanx, Inc. · Aug 2010
FACET SCREW SYSTEM
K101284 · Nuvasive, Inc. · Jul 2010