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Prime Femoral Cement Plug

by Orthopaedic Innovations, Inc.

510(k) K955751

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 NumberK955751 Date26 Jan 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  • Withdrawn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
LZN
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Prime Femoral Cement Plug is a cement obturator, a type of device intended to be implanted to reinforce soft tissue or bone where weakness exists. It is used in orthopedic surgery.

The device is supplied with a product code of LZN and is regulated under 21 CFR 878.3300. It has been cleared by the FDA under the traditional 510(k) clearance type, with the clearance number K955751. The device is intended for use in a surgical setting.

Other devices from Orthopaedic Innovations, Inc.

See all devices from Orthopaedic Innovations, Inc. →

Questions

AI-generated answers, 1 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 Prime Femoral Cement Plug used for?

    The Prime Femoral Cement Plug is used in orthopedic surgery to reinforce soft tissue or bone where weakness exists.

  • How is the Prime Femoral Cement Plug supplied?

    The device is supplied with a product code of LZN and is regulated under 21 CFR 878.3300.

  • Is the Prime Femoral Cement Plug cleared by the FDA?

    Yes, the device has been cleared by the FDA under the traditional 510(k) clearance type, with the clearance number K955751.

  • What type of setting is the Prime Femoral Cement Plug intended for?

    The device is intended for use in a surgical setting.