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Accessories Foe Orthopedic Surgical Procedures

by Eare Consulting Service

510(k) K950592

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 NumberK950592 Date1 Jun 1995ClearedStatusActive

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  • Withdrawn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, 24 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 ACCESSORIES FOR ORTHOPEDIC SURGICAL PROCEDURES are a set of devices used to support orthopedic surgical procedures. They are designed to assist surgeons in performing operations related to bones, joints, and soft tissues.

These accessories are supplied as single-use items and are sterilized prior to distribution. They are intended for use in orthopedic surgeries and are regulated under FDA Class 2, with clearance granted via the Traditional pathway. The devices are stored in a controlled environment to maintain sterility and are available in various sizes to accommodate different surgical needs.

Other devices from Eare Consulting Service

Questions

AI-generated answers, 24 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 are these orthopedic surgical accessories used for?

    These devices are intended to support orthopedic surgical procedures, assisting surgeons in performing operations related to bones, joints, and soft tissues.

  • Are these devices sterile and single-use?

    Yes, the accessories are supplied as single-use items and are sterilized prior to distribution to ensure safety and prevent cross-contamination.

  • What is the regulatory status of these orthopedic accessories?

    These devices are regulated under FDA Class 2 and have been cleared for marketing via the Traditional 510(k) pathway.

  • How are these orthopedic accessories stored?

    The devices are stored in a controlled environment to maintain their sterility until they are ready for use in a surgical setting.