Custom-made orthopaedic surgical guide, non-sterile

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Διαθέσιμο από:

Osseointegration Holdings Pty Ltd

Kατηγορία:

Class I

Κατασκευάζεται από:

Osseointegration International Pty Ltd 1 Richardson Place, Suite 302 Level 3, North Ryde, NSW, 2113 Australia

Θεραπευτική περιοχή:

60826 - Custom-made orthopaedic surgical guide, non-sterile

Θεραπευτικές ενδείξεις:

The Patient Specific Surgical Guide (PSSG) is a medical device designed to assist in the intraoperative orientation of implant components OR indication of the required cut/drill lines to achieve a pre-determined osteotomy geometry. The intended function of the PSSG includes physical interfacing with bone geometry for placement, Outlining the desired cut-line, and/or guiding of surgical instruments (e.g. surgical drill, oscillating cutting saw). The PSSG is indicated to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) where the attending physician requires additional guidance in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw).

Καθεστώς αδειοδότησης:

A

Ημερομηνία της άδειας:

2021-01-15