Orthopaedic bone screw, non-biodegradable, non-sterile
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
01-11-2019
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Tilgængelig fra:
ACRA Regulatory Services Pty Ltd
Klasse:
Class IIb
Fremstillet af:
Tyber Medical 83 South Commerce Way Suite 310, Bethlehem, Pennsylvania, 18017 United States Of America
Terapeutisk område:
56642 - Orthopaedic bone screw, non-biodegradable, non-sterile
Terapeutiske indikationer:
Trauma screw designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone and intended to be for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.
Autorisation status:
A
Autorisation dato:
2019-09-27
