Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy
FDA premarket approval P850022/S034 · decided 2024-02-29
Approval details
- PMA number
- P850022
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2023-12-01
- Decision date
- 2024-02-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for a minor material change to the patient lead cable insulation (i.e., the extruded jacket).
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