Cleared Traditional

K060556 - BRIGIT SURGICAL DEVICE

K060556 is the FDA 510(k) clearance for BRIGIT SURGICAL DEVICE by Zimmer, Inc.. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K060556 · Zimmer, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
151d
Days
Class 2
Risk

K060556 is an FDA 510(k) clearance for the BRIGIT SURGICAL DEVICE. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 31, 2006 after a review of 151 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K060556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2006
Decision Date July 31, 2006
Days to Decision 151 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
3d slower than avg
Panel avg: 148d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K060556.
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K061248 · Medtronic Navigation, Inc. · Aug 2006
VECTORVISION HIP
K060727 · Brainlab AG · Aug 2006
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
K053348 · Howmedica Osteonics Corp. · Aug 2006
BRAINPRO, BRAINPRO ACCESS
K060808 · PAJUNK GmbH Medizintechnologie · Jul 2006
VECTORVISION SPINE
K053159 · Brainlab AG · Jun 2006
IPLAN FLOW
K053164 · Brainlab AG · Mar 2006