Address:6355 SW 8th Street, Suite 101,Miami,FL,33144,US
Device Description : K-wires are stainless steel wires of various lengths and diameters.
Device Class : 1
Duns Number: 024163331
Premarket Exempt : Yes
Prescription Use : No
Device Description : Drill Bits are of various diameters and lengths, and are made of Stainless Steel Drill Bits are of various diameters and lengths, and are made of Stainless Steel, heat-treated and passivated. Some drill bits have laser marked scales to show depth of drill.
Device Class : 1
Duns Number: 024163331
Premarket Exempt : Yes
Prescription Use : No
Device Description : Drivers are of various tips and handle geometry and are made of stainless steel Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel.
Device Class : 1
Duns Number: 024163331
Premarket Exempt : Yes
Prescription Use : No
Device Description : Titanium alloy posts are used to affix the proximal end of the plate to the prox Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No
Device Description : The titanium alloy cortical screws are used to affix the plate to the humerus. T The titanium alloy cortical screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 34mm.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No
Device Description : The titanium alloy cortical screws are used to affix the plate to the humerus. T The titanium alloy cortical screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 34mm.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No
Device Description : The shoulder plates are made of titanium alloy and are designed in right and lef The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No
Device Description : The shoulder plates are made of titanium alloy and are designed in right and lef The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No
Device Description : The shoulder plates are made of titanium alloy and are designed in right and lef The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No
Device Description : The shoulder plates are made of titanium alloy and are designed in right and lef The shoulder plates are made of titanium alloy and are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the anatomy of the proximal humerus. The distal segment of the plate is provided with between 4 (73mm configuration) and 13 (220mm configuration) holes to accommodate 3.5mm diameter locking or non-locking cortical screws. The proximal segment of the plate has 2 locking screw holes and 3 locking post holes. Around the proximal end are also 4 suture clips.
Device Class : 2
Duns Number: 024163331
Premarket Exempt : No
Prescription Use : No