Cleared Traditional

K110321 - TIGER SPINE SYSTEM

K110321 is an FDA 510(k) clearance for TIGER SPINE SYSTEM, manufactured by Corelink, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K110321 · Corelink, LLC · Orthopedic device
Download Printable Device Report (PDF)
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May 2011
Decision
111d
Days
Class 2
Risk

K110321 is an FDA 510(k) clearance for the TIGER SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Corelink, LLC (Round Rock, US). The FDA issued a Cleared decision on May 25, 2011 after a review of 111 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. 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 Corelink, LLC devices

FDA 510(k) Submission Details - K110321

510(k) Number K110321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2011
Decision Date May 25, 2011
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 256
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K110321.
ODALYS PEDICLE SCREW SYSTEM
K111370 · Kalitec Direct, LLC · Sep 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362 · Dio Medical Co., Ltd. · Jul 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · Solco Biomedical Co., Ltd. · Jun 2011
4CIS VANE SPINE SYSTEM
K101818 · Solco Biomedical Co., Ltd. · Feb 2011
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011