SpF Implantable Spinal Fusion Stimulators
FDA premarket approval P850035/S056 · decided 2021-02-17
Approval details
- PMA number
- P850035
- Supplement
- S056
- Supplement type
- 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
- 2021-01-21
- Decision date
- 2021-02-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Qualify and approve an alternate, proposed supplier to provide thermoformed PETG packaging trays and lids utilized in the final sterile pack assembly of EBI OsteoGen Surgically Implantable Bone Growth Stimulators and SpF Implantable Spinal Fusion Stimulators.
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