EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
FDA premarket approval P850035/S021 · decided 1997-07-17
Approval details
- PMA number
- P850035
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR MODEL SPF-XL II
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 1996-10-17
- Decision date
- 1997-07-17
- Days to decision
- 273 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for the Model ST-72 Implant Tester for use with the SpF(R) Implantable Spinal Fusion Stimulator product line (SpF(R) -2T, SpF(R)-4T, SpF(R)-XL, and the SpF(R)-XL II) and the OsteoGen(TM) Implantable Spinal Fusion Stimulator product line.
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