BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
FDA premarket approval P850022/S027 · decided 2016-01-14
Approval details
- PMA number
- P850022
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2015-12-17
- Decision date
- 2016-01-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- QUALIFICATION OF AN ALTERNATE SUPPLIER TO PROVIDE ISOPROPYL ALCOHOL.
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