SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM
FDA premarket approval P850007/S024 · decided 1998-11-03
Approval details
- PMA number
- P850007
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 1998-09-22
- Decision date
- 1998-11-03
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval t use a smaller gauge wire for the Transducer Coil, change from PVC to Neoprene for the inside and outside covers of both front and rear transducer coils, and slightly reduce the thickness of the Kydex material. The device will be marketed under the trade name Spinal-Stim(R) and is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a nonoperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the las
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