PMA P850035S048

Device

SpF Implantable Spinal Fusion Stimulators

Applicant

Ahp Eos Buyer, Inc.

PMA number

P850035

Supplement

S048

Product code

LOE

Decision date

2018-03-30

Classification

Stimulator, Invasive Bone Growth

Generic name

Stimulator, invasive bone growth

Approval order statement

Qualification of an alternate-secondary, contract service provider to provide calibration, maintenance, and rental services of instrumentation and equipment used during qualification and validation activities for the EBI OsteoGen Implantable Gone Growth Stimulators, SpF Implantable Spinal Fusion Stimulators, Biomet EBI Bone Healing System, Biomet SpinalPak, and the Biomet OrthoPak.

Summary

<a href="#main" target="_new">Quick Links: Skip to main page content</a> <a href="#search_form" target="_new">Skip to Search</a> <a href="#fda-topmenu-home" target="_new">Skip to Topics Menu</a> <a href="#footer" target="_new">Skip to Common Links</a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_small.png" alt="Decrease font size" title="Decrease font size"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_medium.png" alt="Return font size to normal" title="Return font size to normal"/></a> <a href="#" target="_new"><img src="/scripts/includes/images/img_fdagov_font_adj_large.png" alt="Increase font size" title="Increase font size"/></a> <a href="http://www.hhs.gov/" target="_new"><img id="rrimg1" border="0" src="/scripts/includes/images/img_fdagov_hhs_masthead_logo_r.png" alt="U.S. Department of Health and Human Services" title="U.S. Department of Health and Human Services"/></a> <a href="https://www.fda.gov/" target="_new"><img src="/scripts/includes/images/gov-fda-new-white.png" alt="FDA, U.S. Food and Drug Administration" border="0" title="FDA, U.S. Food and Drug Administration"/></a> <a href="https://www.fda.gov/news-events/interactive-media" target="_new">Follow FDA</a> <a href="https://www.fda.gov/about-fda/fda-en-espanol" target="_new">En Espa&ntilde;ol</a> <a href="javascript:document.getElementById('search_form').submit();" target="_new"><img src="/scripts/includes/images/img_fdagov_mast_search_button.png" alt="Search" title="Search this site"/></a> <a href="https://www.fda.gov/" target="_new"><span>Home</span></a> <a href="https://www.fda.gov/food" target="_new"><span>Food</span></a> <a href="https://www.fda.gov/Drugs" target="_new"><span>Drugs</span></a> <a href="https://www.fda.gov/Medical-Devices" target="_new"><span>Medical Devices</span></a> <a href="https://www.fda.gov/radiation-emitting-products" target="_new"><span>Radiation-Emitting Products</span></a> <a href="https://www.fda.gov/vaccines-blood-biologics" target="_new"><span>Vaccines, Blood &amp; Biologics</span></a> <a href="https://www.fda.gov/animal-veterinary" target="_new"><span>Animal &amp; Veterinary</span></a> <a href="https://www.fda.gov/cosmetics" target="_new"><span>Cosmetics</span></a> <a href="https://www.fda.gov/tobacco-products" target="_new"><span>Tobacco Products</span></a> <a href="javascript:window.print();" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_print.png" alt="Print" title="Print this page"/></a> <a href="http://www.addthis.com/bookmark.php?u508=true&v=152&amp;username=fdamain" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_share.png" alt="Share" title="Share this page"/></a> <a href="http://www.addthis.com/bookmark.php" target="_new"><img src="/scripts/includes/images/img_fdagov_utility_icon_email.png" alt="E-mail" title="E-mail this page"/></a> <a href="https://www.fda.gov/" target="_new">FDA Home</a> <a href="http://www.fda.gov/MedicalDevices/default.htm" target="_new">Medical Devices</a> <a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm" target="_new">Databases</a> <a href="/scripts/cdrh/devicesatfda/index.cfm" target="_new"><img src="../images/supersearch.gif" align="left" border="0" alt="Super Search Devices@FDA"></a>