Cleared Traditional

K071435 - NUVASIVE OCT SYSTEM

K071435 is an FDA 510(k) clearance for NUVASIVE OCT SYSTEM, manufactured by Nuvasive, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K071435 · Nuvasive, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
75d
Days
Class 2
Risk

K071435 is an FDA 510(k) clearance for the NUVASIVE OCT SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on August 6, 2007 after a review of 75 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 Nuvasive, Inc. devices

FDA 510(k) Submission Details - K071435

510(k) Number K071435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2007
Decision Date August 06, 2007
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 288
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K071435.
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K063453 · Elite Surgical Supplies (Pty), Ltd. · Aug 2007
PSS SYSTEM
K071438 · Spinal USA · Aug 2007
DELTA SPINAL FUSION SYSTEM
K071857 · Jemo Spine, LLC · Aug 2007
PILLAR PEDICLE SCREW SYSTEM
K071743 · The 4th Column, LLC · Jul 2007
SYNAPSE SYSTEM
K070573 · Synthes Spine Co.Lp · Jun 2007
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
K070295 · Trinity Orthopedics, LLC · May 2007