Skip to content

Osteostim Implantable Bone Growth Stimulator

by Ahp Eos Buyer, Inc.

PMA P790005

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

1 closed

Documents

PMA P790005↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP790005 Date4 Apr 1984ApprovedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0286-2019 FDA Class I initiated 19 Feb 2018

    Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Osteostim(R)
Generic Name
Stimulator, invasive bone growth
PMA Number
FDA Product Code
LOE
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APPR Approved
PMA Supplement
S023

Overview

AI-generated summary, 18 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 Osteostim is an invasive bone growth stimulator designed for orthopedic applications. It functions as a medical device intended to promote bone healing through electrical stimulation.

This device is manufactured by Ahp Eos Buyer, Inc. and is regulated under FDA PMA number P790005. It is categorized within the orthopedic advisory committee classification for clinical use.

Other devices from Ahp Eos Buyer, Inc.

Questions

AI-generated answers, 18 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 primary function of the Osteostim?

    The Osteostim is an invasive bone growth stimulator designed to assist in the process of bone healing.

  • Who is the manufacturer of this device?

    The Osteostim is manufactured by Ahp Eos Buyer, Inc., located in Parsippany, New Jersey.

  • Is the Osteostim regulated by the FDA?

    Yes, the device is regulated under FDA PMA number P790005, which indicates it has undergone the Premarket Approval process.