Cleared Traditional

K101364 - LANX FACET SCREW SYSTEM

K101364 · Lanx, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
94d
Days
-
Risk

K101364 is an FDA 510(k) clearance for the LANX FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Lanx, Inc. (Broomfield, US). The FDA issued a Cleared decision on August 16, 2010 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Lanx, Inc. devices

FDA 510(k) Submission Details - K101364

510(k) Number K101364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2010
Decision Date August 16, 2010
Days to Decision 94 days
Submission Type Traditional
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
28d faster than avg
Panel avg: 122d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 55
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K101364.
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · Osteomed LP · Sep 2010
FACET SCREW SYSTEM
K101284 · Nuvasive, Inc. · Jul 2010
FIXCET SPINAL FACET SCREW SYSTEM
K100154 · X-Spine Systems, Inc. · May 2010
SPINEOLOGY FACET SCREW
K092464 · Spineology, Inc. · Nov 2009