Address:Industriestrasse 2,ALZENAU Bavaria,DE
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic f The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
Device Class : 2
Duns Number: 344203948
Premarket Exempt : No
Prescription Use : Yes
Device Description : The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic f The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
Device Class : 2
Duns Number: 344203948
Premarket Exempt : No
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : An orthopedic manual surgical instrument is a nonpowered hand-held device intend An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Device Class : 1
Duns Number: 344203948
Premarket Exempt : Yes
Prescription Use : Yes