PMA P850007S024

Device: SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S024
Product code: LOF
Decision date: 1998-11-03
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order 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 last surgery.

Current openFDA PMA Record#

Device: SPINAL-STIM LITE, MODELS 212L AND 212LE. SPINAL FUSION SYSTEM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S024
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1998-11-03
Decision code: APPR
Date received: 1998-09-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 last surgery.