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Neurosurgical Drills: Stille, Hudson

by Zinnanti Surgical Instruments, Inc.

510(k) K892531

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 NumberK892531 Date5 May 1989ClearedStatusActive

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  • Withdrawn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
HBG
Device Class
Class II
Regulation
21 CFR Part 882.4300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

Neurosurgical drills are manual instruments used for drilling in neurosurgical procedures. These devices are designed for precision in neurosurgical applications, including Stille and Hudson models.

The device is supplied as a non-sterile, reusable instrument. It is not MRI compatible and should be stored according to manufacturer instructions. The device has FDA 510(k) clearance with product code HBG and is classified under Drills, Burrs, Trephines & Accessories (Manual).

Other devices from Zinnanti Surgical Instruments, Inc.

See all devices from Zinnanti Surgical Instruments, Inc. →

Questions

AI-generated answers, 6 Oct 2026

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

  • What are neurosurgical drills Stille Hudson used for?

    Neurosurgical drills Stille Hudson are manual instruments designed for precision drilling in neurosurgical procedures. They are specifically engineered for neurosurgical applications to ensure accuracy during surgical interventions.

  • How are these neurosurgical drills supplied and are they sterile?

    The neurosurgical drills are supplied as non-sterile, reusable instruments. They require proper sterilization before each use according to standard medical protocols, as they are not provided in a sterile state by the manufacturer.

  • What is the regulatory status of these neurosurgical drills?

    These neurosurgical drills have FDA 510(k) clearance with product code HBG and are classified under Drills, Burrs, Trephines & Accessories (Manual). They are substantially equivalent to predicate devices and are intended for manual use in neurosurgical procedures.

  • Are these neurosurgical drills MRI compatible?

    No, these neurosurgical drills are not MRI compatible. They should not be used in MRI environments as they may interfere with the imaging process or pose safety risks in such settings.

  • How should these neurosurgical drills be stored?

    These neurosurgical drills should be stored according to the manufacturer's instructions. Proper storage conditions help maintain the instrument's functionality and longevity between uses.