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Spinal Fusion Stimulator

by Ahp Eos Buyer, Inc.

PMA P850035

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P850035↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP850035 Date30 Apr 1987ApprovedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0287-2019 FDA Class I initiated 19 Feb 2018

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

  • 2 recalls, same reason

    • Terminated Z-2119-2017 FDA Class I initiated 20 Apr 2017
    • Terminated Z-2118-2017 FDA Class I initiated 20 Apr 2017

    Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Full name
Spf Spinal Fusion Stimulator
Trade Name
SpF® Implantable Spinal Fusion Stimulator
Generic Name
Stimulator, invasive bone growth
PMA Number
FDA Product Code
LOE
Device Class
Class III
Advisory Committee
Orthopedic
FDA Decision
APPR Approved

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 Spinal Fusion Stimulator is an invasive bone growth stimulator designed to promote spinal fusion. Classified as a Class III device under FDA regulations, it is intended for implantation to electrically stimulate bone growth in spinal fusion procedures, aiding in the consolidation of vertebrae.

This device is supplied sterile and intended for single-use implantation by a surgeon in an operating room setting. It is regulated under an FDA Premarket Approval (PMA) with PMA number P850035 and falls under the product code LOE. Proper storage requires adherence to sterile packaging instructions until use.

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