Cleared Traditional

K090272 - SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)

K090272 is an FDA 510(k) clearance for SPETZLER SCALP RETRACTOR CLAMPS (VARIOU..., manufactured by Cardinal Health, Inc.. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K090272 · Cardinal Health, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
42d
Days
Class 2
Risk

K090272 is an FDA 510(k) clearance for the SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES). Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on March 18, 2009 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - the FDA neurology device 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 Cardinal Health, Inc. devices

FDA 510(k) Submission Details - K090272

510(k) Number K090272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2009
Decision Date March 18, 2009
Days to Decision 42 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 148d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
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 Neurology devices follow this clearance model.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 31
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K090272.
SPOTLIGHT ACCESS SYSTEM
K113273 · Johnson & Johnson · Jan 2012
SPOTLIGHT ACCESS SYSTEM
K112913 · Johnson & Johnson · Dec 2011
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010
INSTRUMED RETRACTORS
K071771 · Instrumed International, Inc. · Aug 2007
FLEX ARM RETRACTOR SYSTEM
K071338 · Koros USA, Inc. · May 2007
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006