Taiwan FDA registration d7a68adc63d922777a3e170db6edcb9b

"St. Francis" interspinal decompression system

TW: "聖法蘭西斯" 脊突間減壓系統

Taiwan·Risk Class 3·ST. FRANCIS MEDICAL TECHNOLOGIES, INC.·Registered Nov 25, 2008 – Nov 25, 2013Cancelled

Registration details

Analysis ID: d7a68adc63d922777a3e170db6edcb9b
Customs Code: DHA00601960009

Company information

Manufacturer: ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
Manufacturer Country: United States
Authorized Representative: JUBILANT SUNRISE SCIENTIFIC CO., LTD.

Product details

Intended Use: 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.
Product Type (Level 1): N Orthopedics
Import Information: import

Dates and status

Registration Date: Nov 25, 2008
Expiry Date: Nov 25, 2013
Cancellation Date: Jun 16, 2015

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

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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