Cleared Special

K090767 - PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER

K090767 · Interventional Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
80d
Days
-
Risk

K090767 is an FDA 510(k) clearance for the PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Interventional Spine, Inc. (Irvine, US). The FDA issued a Cleared decision on June 11, 2009 after a review of 80 days - a notably fast clearance cycle.

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. 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 - K090767

510(k) Number K090767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 23, 2009
Decision Date June 11, 2009
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K090767.
SPINEOLOGY FACET SCREW
K092464 · Spineology, Inc. · Nov 2009
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
LIFE SPINE FACET SCREW SPINAL SYSTEM
K090865 · Life Spine · Jun 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009
SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
K082795 · Interventional Spine, Inc. · Dec 2008
TRANS1 FACET SCREW
K073515 · Trans1 Incorporated · Mar 2008