"St. Francis" interspinal decompression system - Taiwan Registration d7a68adc63d922777a3e170db6edcb9b
Access comprehensive regulatory information for "St. Francis" interspinal decompression system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number d7a68adc63d922777a3e170db6edcb9b and manufactured by ST. FRANCIS MEDICAL TECHNOLOGIES, INC.. The authorized representative in Taiwan is JUBILANT SUNRISE SCIENTIFIC CO., LTD..
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Device Details
Product Details
The "St. Francis" Interprocess Decompression System (X STOP) is indicated for the treatment of patients aged 50 years or older who have secondary intermittent claudication (thickening of the ligamentum flavum, narrowing of the crypt and/or narrowing of the central vertebral cavity as evidenced by X-ray, magnetic resonance and/or computed tomography evidence) due to a diagnosis of lumbar stenosis. In addition, X STOP is suitable for patients with mild impairment of body function, reduced leg/buttocks/groin pain when bending, plus patients with or without back pain, who have been treated with non-surgical well-being for at least 6 months. Surgical treatment should not exceed two segments, and X STOP can be implanted in one or two lumbar vertebrae.
N Orthopedics
import
Dates and Status
Nov 25, 2008
Nov 25, 2013
Jun 16, 2015
Cancellation Information
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