SpF Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S051 · decided 2018-11-02
Approval details
- PMA number
- P850035
- Supplement
- S051
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SpF Implantable Spinal Fusion Stimulators
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2018-04-02
- Decision date
- 2018-11-02
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for implementation of an additional finished device cleaning process and associated new, semi- automated, PLC cleaning equipment to further ensure adequate removal of manufacturing materials and residue from finished devices has occurred through conformance to cleanliness requirements in accordance with Zimmer Biomet GES 09802 Implant Residual Materials and Endotoxin Limits.
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