Cleared Traditional

K100377 - DIAMONDBACK SPINAL SYSTEM

K100377 is an FDA 510(k) clearance for DIAMONDBACK SPINAL SYSTEM, manufactured by Eminent Spine. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K100377 · Eminent Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
69d
Days
Class 2
Risk

K100377 is an FDA 510(k) clearance for the DIAMONDBACK SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Eminent Spine (Chesterland, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Eminent Spine devices

FDA 510(k) Submission Details - K100377

510(k) Number K100377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date April 22, 2010
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 185
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K100377.
LIFE SPINE INTERSPINOUS FIXATION SYSTEM
K100407 · Life Spine · Nov 2010
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
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K100851 · K2m, Inc. · Aug 2010
AEGIS & AEGIS II SPINAL SYSTEM
K092076 · Corentec Co., Ltd. · Apr 2010
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575 · Ldr Spine USA · Mar 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · Spineart · Mar 2010