MODEL SPF-60 SPINAL FUSION STIMULATOR
FDA premarket approval P850035/S029 · decided 2002-12-06
Approval details
- PMA number
- P850035
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL SPF-60 SPINAL FUSION STIMULATOR
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2002-06-13
- Decision date
- 2002-12-06
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR THE MODEL SPF-60 IMPLANTABLE SPINAL FUSION STIMULATOR AND IS INDICATED FOR USE AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
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