Cleared Special

K100575 - LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

K100575 is an FDA 510(k) clearance for LDR SPINE USA SPINE TUNE TL SPINE SYSTEM, manufactured by Ldr Spine USA. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 30-day FDA review.

K100575 · Ldr Spine USA · Orthopedic device
Download Printable Device Report (PDF)
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Mar 2010
Decision
30d
Days
Class 2
Risk

K100575 is an FDA 510(k) clearance for the LDR SPINE USA SPINE TUNE TL SPINE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Ldr Spine USA (Austin, US). The FDA issued a Cleared decision on March 31, 2010 after a review of 30 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.

View all Ldr Spine USA devices

FDA 510(k) Submission Details - K100575

510(k) Number K100575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2010
Decision Date March 31, 2010
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 184
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K100575.
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
K102331 · Ldr Spine USA · Oct 2010
RANGE SPINAL SYSTEM
K100851 · K2m, Inc. · Aug 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · Corentec Co., Ltd. · Apr 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · Spineart · Mar 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K100138 · Alphatec Spine, Inc. · Feb 2010
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K093077 · Alphatec Spine, Inc. · Dec 2009