Cleared Special

K080547 - ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106

K080547 is an FDA 510(k) clearance for ORTHOPILOT NEXT GENERATION, manufactured by Aesculap Implant System, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Special 510(k) pathway after a 85-day FDA review.

K080547 · Aesculap Implant System, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
85d
Days
Class 2
Risk

K080547 is an FDA 510(k) clearance for the ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080547

510(k) Number K080547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2008
Decision Date May 23, 2008
Days to Decision 85 days
Submission Type Special
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
64d faster than avg
Panel avg: 149d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

HAW Device Classification - Class 2, Special Controls

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 Consultant

Aesculap AG
Kathy Racosky

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 404
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