ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
FDA premarket approval P850022/S017 · decided 2010-10-15
Approval details
- PMA number
- P850022
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM & SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2009-09-16
- Decision date
- 2010-10-15
- Days to decision
- 394 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR CHANGES TO THE HARDWARE, SOFTWARE, COMPONENTS, AND SPECIFICATIONSOF THE DEVICE.
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