SPINAL-STIM LITE SPINAL FUSION SYSTEM
FDA premarket approval P850007/S019 · decided 1997-09-19
Approval details
- PMA number
- P850007
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SPINAL-STIM LITE SPINAL FUSION SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 1996-06-12
- Decision date
- 1997-09-19
- Days to decision
- 464 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for the Spinal-Stim(R) Lite Spinal Fusion System, Model 212L. 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 ans as a nonooperative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since the last surgery.
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