"Medtronic" Betty cervical intervertebral disc system - Taiwan Registration 0f4e5cbf45ae24406ef2f8da7ec435c5
Access comprehensive regulatory information for "Medtronic" Betty cervical intervertebral disc system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 0f4e5cbf45ae24406ef2f8da7ec435c5 and manufactured by MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..
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Device Details
Product Details
It is suitable for disc reconstruction in patients with bone maturity in single-section laminectomy in the C3-C7 segment, and confirmed by refractory radiculopathy and/or spinal cord disease as symptomatic cervical degenerative disc disease. The "Medtronic" Betty cervical disc is implanted through an open anterior side. Refractory neuropathy and/or spinal cord disease should present with at least one of the following symptoms that produce symptomatic nerve root and/or spinal cord compression, including a documented history of the patient (eg, pain [neck and/or arm pain], functional insufficiency, and/or neurological deficits) and radiological examinations (e.g., CT, MRI, X-ray, etc.) showing 1) a herniated disc, and/or 2) bone spur formation. Patients should be those who have not responded to non-surgical therapy for more than 3 months, or who have symptoms or symptoms of progressive nerve root/spinal cord compression during the ongoing non-surgical management phase. It should not be used for revision surgery from previous surgery.
N Orthopedics
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Dates and Status
May 30, 2008
May 30, 2013
Oct 03, 2013
Cancellation Information
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