Cleared Traditional

K944188 - SPINAL MARKER

K944188 is an FDA 510(k) clearance for SPINAL MARKER, manufactured by Leibinger L.P.. The device is a Class 1 Orthopedic device with product code LXH cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K944188 · Leibinger L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
230d
Days
Class 1
Risk

K944188 is an FDA 510(k) clearance for the SPINAL MARKER. Classified as Orthopedic Manual Surgical Instrument (product code LXH), Class I - General Controls.

Submitted by Leibinger L.P. (Dallas, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 230 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. 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 Leibinger L.P. devices

FDA 510(k) Submission Details - K944188

510(k) Number K944188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date April 13, 1995
Days to Decision 230 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence.

LXH Device Classification - Class 1, General Controls

Product Code LXH Orthopedic Manual Surgical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LXH Orthopedic Manual Surgical Instrument

All 30
Devices cleared under the same product code (LXH) and FDA review panel - the closest regulatory comparables to K944188.
MICROPERFORATION INSTRUMENT
K001507 · Smith & Nephew, Inc. · Jun 2000
ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
K952495 · Orthopedic Systems, Inc. · Jan 1996
ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY
K943873 · Orthomet, Inc. · Apr 1995
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR
K941896 · Depuy, Inc. · Nov 1994
HYPERFLEX FLEXIBLE GUIDEWIRES
K941711 · Linvatec Corp. · Aug 1994
STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH
K941605 · Stryker Corp. · Aug 1994