PMA P850007S021

Device: SPINAL-STIM LITE SPINAL FUSION SYSTEM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S021
Product code: LOF
Decision date: 1998-05-14
Classification: Stimulator, Bone Growth, Non-invasive
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for the Spinal-Stim(R) Lite Spinal Fusion System, Model 212LE. 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 SPINAL FUSION SYSTEM
Applicant: Orthofix, Inc.
PMA number: P850007
Supplement: S021
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 1998-05-14
Decision code: APPR
Date received: 1998-03-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Spinal-Stim(R) Lite Spinal Fusion System, Model 212LE. 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.