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Meniscus Extractor

by Ortho Pared Instruments, Inc.

510(k) K820225

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 NumberK820225 Date4 Feb 1982ClearedStatusActive

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  • Withdrawn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, 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.

A meniscus extractor is a surgical instrument designed for the removal of meniscal tissue during orthopedic procedures. It is used to grasp and extract damaged or torn meniscus from the knee joint.

This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user. It is indicated for use in orthopedic surgical settings and has received FDA 510(k) clearance (K820225) as substantially equivalent to a legally marketed predicate device.

Other devices from Ortho Pared 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 is the meniscus extractor used for?

    The meniscus extractor is a surgical instrument designed for the removal of meniscal tissue during orthopedic procedures. It is used to grasp and extract damaged or torn meniscus from the knee joint, as stated in the device description.

  • Is the meniscus extractor supplied sterile or non-sterile?

    The meniscus extractor is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user, according to the device specifications.

  • What regulatory clearance does the meniscus extractor have?

    The meniscus extractor has received FDA 510(k) clearance (K820225) as substantially equivalent to a legally marketed predicate device, as indicated in the device data.

  • Who manufactures the meniscus extractor?

    The meniscus extractor is manufactured by Ortho Pared Instruments, Inc., as listed in the device data under the manufacturer field.

  • What is the product code for the meniscus extractor?

    The product code for the meniscus extractor is HRX, as specified in the device data under the specifications section.