Cleared Traditional

K072914 - NATURAL BRIDGE LP TRANSVERSE CONNECTORS

K072914 is the FDA 510(k) clearance for NATURAL BRIDGE LP TRANSVERSE CONNECTORS by K2m, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K072914 · K2m, Inc. · Orthopedic device
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Jan 2008
Decision
83d
Days
Class 2
Risk

K072914 is an FDA 510(k) clearance for the NATURAL BRIDGE LP TRANSVERSE CONNECTORS. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on January 3, 2008 after a review of 83 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 K2m, Inc. devices

Submission Details

510(k) Number K072914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2007
Decision Date January 03, 2008
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K072914.
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · Blackstone Medical, Inc. · Mar 2008
MODIFICATION TO STRYKER SPINE OASYS SYSTEM
K080143 · Stryker Spine · Feb 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026 · Pioneer Surgical Technology · Jan 2008
PIONEER LOWTOP SPINAL ROD SYSTEM
K072187 · Pioneer Surgical Technology · Oct 2007
Optima ZS Transition Screw
K071880 · Zimmer Spine, Inc. · Oct 2007
NUVASIVE OCT SYSTEM
K071435 · Nuvasive, Inc. · Aug 2007