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Conmed Linvatec Osprey Drill System

by Conmed Linvatec

510(k) K080444

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080444 Date2 Apr 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HBC
Device Class
Class II
Regulation
21 CFR Part 882.4360
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Conmed Linvatec Osprey Drill System is an electric motor drill designed for cutting, drilling, and manipulating bone and soft tissue. It functions as a powered surgical instrument for use in various surgical specialties.

This device is classified as a class 2 medical device under regulation number 882.4360. It has received FDA 510(k) clearance under the submission number K080444.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Conmed Linvatec Osprey Drill System?

    This device is an electric motor drill engineered for cutting, drilling, and manipulating both bone and soft tissue during surgical procedures.

  • What is the regulatory classification of this drill system?

    The Osprey Drill System is classified as a class 2 medical device under regulation number 882.4360 and has received FDA 510(k) clearance under submission number K080444.

  • In which surgical specialties is this drill used?

    The system is designed as a powered surgical instrument for use across various surgical specialties, with the device filing associated with the neurology advisory committee.