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Arthroscopic Leg Holder

by Stryker Corp.

510(k) K811861

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 NumberK811861 Date16 Jul 1981ClearedStatusActive

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  • Withdrawn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
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
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.

An arthroscopic leg holder is a device designed to provide secure and comfortable support for the patient's leg during arthroscopic procedures. It is engineered for use in orthopedic surgeries to maintain proper leg positioning.

This leg holder can be used with or without a tourniquet cuff by employing the leg holder pad. It is interchangeable for right or left legs and allows adjustment in height and tilt to maintain appliance position relative to the thigh. The base is mobile on its support, enabling positioning flexibility. It is supplied as a reusable device and was authorized via FDA 510(k) clearance under K811861 with product code HRX.

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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 ARTHROSCOPIC LEG HOLDER used for?

    The ARTHROSCOPIC LEG HOLDER is designed to provide secure and comfortable support for the patient's leg during arthroscopic procedures, maintaining proper leg positioning in orthopedic surgeries.

  • Is the ARTHROSCOPIC LEG HOLDER reusable or single-use?

    The ARTHROSCOPIC LEG HOLDER is supplied as a reusable device, meaning it can be cleaned and used multiple times following appropriate reprocessing procedures.

  • Can the ARTHROSCOPIC LEG HOLDER be used with a tourniquet cuff?

    Yes, the ARTHROSCOPIC LEG HOLDER can be used with or without a tourniquet cuff by employing the leg holder pad, allowing flexibility depending on surgical requirements.

  • Is the ARTHROSCOPIC LEG HOLDER suitable for both right and left legs?

    The ARTHROSCOPIC LEG HOLDER is interchangeable for right or left legs, enabling use on either side without requiring a different device.

  • What regulatory pathway was used for the ARTHROSCOPIC LEG HOLDER?

    The ARTHROSCOPIC LEG HOLDER was authorized via FDA 510(k) clearance under K811861, demonstrating substantial equivalence to a legally marketed predicate device.