SPF PLUS 60/W AND SPF-PLUS 60/M
FDA premarket approval P850035/S031 · decided 2007-06-21
Approval details
- PMA number
- P850035
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPF PLUS 60/W AND SPF-PLUS 60/M
- Generic name
- Stimulator, invasive bone growth
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2007-02-23
- Decision date
- 2007-06-21
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- LOE
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR DEVICE MODIFICATIONS TO INCORPORATE IDENTICAL BATTERY CHEMISTRY AND IMPLANT TESTER CONFIGURATION AS APPROVED IN THE SPF-XL IIB DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPF-PLUS 60/W AND SPF-PLUS 60/M AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS IN 1 OR 2 LEVELS.
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