PMA P850022S031

Device: Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850022
Supplement: S031
Product code: LOF
Decision date: 2022-11-23
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations.

Current openFDA PMA Record#

Device: Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator
Applicant: Ahp Eos Buyer, Inc.
PMA number: P850022
Supplement: S031
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2022-11-23
Decision code: OK30
Date received: 2022-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualify an alternate contract service provider to provide calibration services for instrumentation and lab equipment utilized to support manufacturing and quality operations.