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DORO Sterile Disposable Skull Pins

by Pro-Med Instruments GmbH

510(k) K193438

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193438 Date2 Jun 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
DORO Sterile Disposable Skull Pins (Stainless Steel), DORO Sterile Disposable Skull Pins (Titanium)
510(k) Number
FDA Product Code
HBL
FDA applicant
Pro Med Instruments GmbH
Device Class
Class II
Regulation
21 CFR Part 882.4460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

Doro Sterile Disposable Skull Pins are neurosurgical skull clamp accessories designed to fixate the head during surgical procedures. These pins are inserted into the receptacles of a skull clamp to provide rigid and secure patient positioning.

These devices are supplied in sterile packaging for single-use applications. They are available in stainless steel or titanium materials and have received FDA 510(k) clearance.

Other devices from Pro-Med Instruments GmbH

See all devices from Pro-Med Instruments GmbH →

Questions

AI-generated answers, 22 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 intended use of DORO Sterile Disposable Skull Pins?

    These pins are designed as accessories for neurosurgical skull clamps. They are inserted into the clamp receptacles to provide rigid and secure patient head positioning during surgical procedures.

  • Are these skull pins intended for reuse?

    No, these devices are designed for single-use applications only. They are supplied in sterile packaging to ensure patient safety and must be disposed of after the surgical procedure is complete.

  • What material options are available for these pins?

    DORO Sterile Disposable Skull Pins are available in two material types: stainless steel or titanium. Both versions are designed to function within neurosurgical skull clamps to maintain patient positioning.

  • What is the regulatory status of these skull pins?

    These devices have received FDA 510(k) clearance under the Neurology advisory committee. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.