Cleared Traditional

K080444 - CONMED LINVATEC OSPREY DRILL SYSTEM

K080444 is an FDA 510(k) clearance for CONMED LINVATEC OSPREY DRILL SYSTEM, manufactured by Conmed Linvatec. The device is a Class 2 Neurology device with product code HBC cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K080444 · Conmed Linvatec · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
43d
Days
Class 2
Risk

K080444 is an FDA 510(k) clearance for the CONMED LINVATEC OSPREY DRILL SYSTEM. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on April 2, 2008 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - 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 Conmed Linvatec devices

FDA 510(k) Submission Details - K080444

510(k) Number K080444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date April 02, 2008
Days to Decision 43 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
105d faster than avg
Panel avg: 148d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBC Device Classification - Class 2, Special Controls

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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 - HBC Motor, Drill, Electric

All 21
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K080444.
PRIMADO2 TOTAL SURGICAL SYSTEM
K132264 · Nakanishi, Inc. · Dec 2013
D4000 DRIVE SYSTEM
K130497 · Linvatec Corporation D/B/A Conmed Linvatec · Mar 2013
PRIMADO
K083112 · Nakanishi, Inc. · Apr 2009
MICROPOWER HAND PIECE HIGH SPEED DRILL
K060260 · Linvatec Corp. · Apr 2006
MICROSPEED UNI MOTOR SYSTEM
K053526 · Aesculap, Inc. · Jan 2006
THE BIOPLATE BATTERY POWERED DRILL
K022986 · Bioplate, Inc. · Nov 2002