Cleared Traditional

K130830 - INTEGRA LAMINOPLASTY SYSTEM

K130830 is the FDA 510(k) clearance for INTEGRA LAMINOPLASTY SYSTEM by Seaspine, Inc.. It is a Class 2 Orthopedic device (product code NQW) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K130830 · Seaspine, Inc. · Orthopedic device
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May 2013
Decision
44d
Days
Class 2
Risk

K130830 is an FDA 510(k) clearance for the INTEGRA LAMINOPLASTY SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on May 9, 2013 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Seaspine, Inc. devices

Submission Details

510(k) Number K130830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2013
Decision Date May 09, 2013
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 22
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K130830.
HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System
K171413 · Globus Medical, Inc. · Jul 2017
Xspan Laminoplasty Fixation System
K160114 · X-Spine Systems, Inc. · Mar 2016
Integra Laminoplasty System
K150469 · Seaspine, Inc. · Mar 2015
CANOPY LAMINOPLASTY FIXATION SYSTEM
K121732 · Globus Medical, Inc. · Oct 2012
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
K113218 · Pioneer Surgical Technology, Inc. · Jan 2012