PMA P850022S028

Device: BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850022
Supplement: S028
Product code: LOF
Decision date: 2016-12-08
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Qualification of an alternate supplier to provide electronic printed circuit boards (PCBs) for the three device systems. The change is being made to qualify an alternate secondary-supplier for the PCBs to complement existing approved suppliers in order to further secure the supply chain for critical components to these device systems. The following Zimmer Biomet manufacturing and distribution facility is affected by the changes: EBI Patient Care Inc., Guaynabo, Puerto Rico.

Current openFDA PMA Record#

Device: BIOMET ORTHOPAK NON INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON INVASIVE SPINE FUSION STIMULATOR SYSTEM
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850022
Supplement: S028
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2016-12-08
Decision code: OK30
Date received: 2016-11-08
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of an alternate supplier to provide electronic printed circuit boards (PCBs) for the three device systems. The change is being made to qualify an alternate secondary-supplier for the PCBs to complement existing approved suppliers in order to further secure the supply chain for critical components to these device systems. The following Zimmer Biomet manufacturing and distribution facility is affected by the changes: EBI Patient Care Inc., Guaynabo, Puerto Rico.