BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
FDA premarket approval P850022/S018 · decided 2011-08-11
Approval details
- PMA number
- P850022
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOMET ORTHOPAK NON-INVASIVE BONE STIMULATOR SYSTEM & BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2011-06-13
- Decision date
- 2011-08-11
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE MODIFICATION OF THE SYSTEM SOFTWARE TO INCLUDE AN ADDITIONAL LINE OF CODE WHICH WOULD ALLOW THE REAL-TIME CLOCK TO RESET TO 'DAY ZERO' AFTER AN ELAPSED 365 DAYS, THIS RESET WOULD ALLOW YOUR DEVICE TO REMAIN FUNCTIONAL AFTER 365 DAYS OF INACTIVITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM AND ARE INDICATED FOR THE FOLLOWING: 1) THE BIOMET ORTHOPAK N
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