Taiwan FDA registration 0f4e5cbf45ae24406ef2f8da7ec435c5

"Medtronic" Betty cervical intervertebral disc system

TW: “美敦力”貝提頸椎椎間盤系統

Taiwan·Risk Class 3·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Registered May 30, 2008 – May 30, 2013Cancelled

Registration details

Analysis ID: 0f4e5cbf45ae24406ef2f8da7ec435c5
Customs Code: DHA00601906704

Company information

Manufacturer: MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Manufacturer Country: Germany
Authorized Representative: MEDTRONIC (TAIWAN) LTD.

Product details

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

Dates and status

Registration Date: May 30, 2008
Expiry Date: May 30, 2013
Cancellation Date: Oct 03, 2013

Cancellation information

Status: Logged out
Reason: 自請註銷

About this record

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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