MEDTRONIC, INC. A14BX025150090 RapidCross™

Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes

Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes

Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated for applications in oral andmaxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled(artificial or degenerative) bone defects, e.g.:- Defects after the extirpation of bone cysts- Augmentation of an atrophied alveolar ridge- Sinus lift or sinus floor elevation (subantral augmentation)- Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects- Defects after operative removal of retained teeth or corrective osteotomies

Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Percutaneous Transluminal Angioplasty (PTA) Catheter

PTA A14BX025150090 RAPIDCROSS V03

PTA A14BX025150090 RAPIDCROSS V04

PTA Rapid Exchange Balloon Dilatation Catheter

CASTABLE ABUTMENT

Optional Power Transfer Arm Assembly. Installs on the the side rails of the Motion Concepts Power Positioning System. (Weight capacity = 175 lb.) Includes actuator motor. Available for left or right side mounting.

Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes

Device Name: OSBONE® DENTALlndications for Use:OSBONE® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g.:- Defects after removal of bone cysts- Augmentation of the atrophied alveolar ridge- Sinus lift and sinus floor elevation (subantral augmentation)- Filling of alveolar defects following tooth extraction for alveolar ridge preservation- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects- Support function for a membrane in controlled tissue regeneration (CTR)- Defects after surgical removal of retained teeth or corrective osteotomies- Other multi-walled bone defects of the alveolar processes

Device Name: Curasan OSSEOLIVE® DENTALlndications for Use:OSSEOLIVE® DENTAL is indicated for applications in oral andmaxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled(artificial or degenerative) bone defects, e.g.:- Defects after the extirpation of bone cysts- Augmentation of an atrophied alveolar ridge- Sinus lift or sinus floor elevation (subantral augmentation)- Filling of alveolar defects after tooth extraction for preservation of the alveolar ridge- Filling of extraction defects to create an implant bed- Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects- Defects after operative removal of retained teeth or corrective osteotomies

Device Name: CERASORB® M DENTALlndications for Use:CERASORB® M DENTAL is recommended for:- Augmentation or reconstructive treatment of the alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection, apicoectomy and cystectomy- Filling of extraction sockets to enhance preservation of the alveolar ridge- Elevation of the maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)