Cleared Special

K120760 - LDR SPINE SPINETUNE TL SPINAL SYSTEM

K120760 is an FDA 510(k) clearance for LDR SPINE SPINETUNE TL SPINAL SYSTEM, manufactured by Ldr Spine USA, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 106-day FDA review.

K120760 · Ldr Spine USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
106d
Days
Class 2
Risk

K120760 is an FDA 510(k) clearance for the LDR SPINE SPINETUNE TL SPINAL SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Ldr Spine USA, Inc. (Austin, US). The FDA issued a Cleared decision on June 27, 2012 after a review of 106 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K120760

510(k) Number K120760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2012
Decision Date June 27, 2012
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 303
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K120760.
INSTINCT JAVA SYSTEM
K122592 · Zimmer Spine · Jan 2013
GALLEON PEDICLE SCREW SYSTEM
K122814 · Everest Spine, LLC · Dec 2012
FORTEX PEDICLE SCREW SYSTEM
K120832 · X-Spine Systems, Inc. · Oct 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · K2m, Inc. · Jun 2012
S 100 PEDICLE SCREW SYSTEM
K111940 · Renovis Surgical Technologies, LLC · May 2012
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
K120353 · Bm Korea Co., Ltd. · May 2012