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Steinman Pin

by American Medical Specialties, Inc.

510(k) K960483

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 NumberK960483 Date9 Apr 1996ClearedStatusActive

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  • Withdrawn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
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Steinman Pin is an orthopedic device. It is classified under the product code HTY.

The Steinman Pin is supplied by American Medical Specialties, Inc. and has received FDA 510K authorization. The device is associated with the advisory committee description Orthopedic.

Other devices from American Medical Specialties, Inc.

  • Burrs

    Class I
  • K-Wire

    Class II
  • Surgical Saw Blades

    Class I

Questions

AI-generated answers, 23 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 Steinman Pin used for?

    The Steinman Pin is an orthopedic device, but its specific use is not detailed in the provided information.

  • How is the Steinman Pin supplied?

    The Steinman Pin is supplied by American Medical Specialties, Inc.

  • What regulatory authorization has the Steinman Pin received?

    The Steinman Pin has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.