Address:846 SILVER SPGS,Helotes,TX,78023,US
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 09x09x07mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 09mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 11x10x10mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 11mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 11x15x13mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 11mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 13x10x10mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 13mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 15x12x12mm with a 1.5mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 15mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 1.8mm Pull Pins; 1ea 1.8mm Drill Bit (color band of yellow)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 15x12x12mm with a 2.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 15mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 18x18x15mm with a 2.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 18mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x20x20mm with a 2.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 2.4mm Pull Pins; 1ea 2.4mm Drill Bit (color band of red)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteo Product received FDA 510(k) clearance for: Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs, and in flat bone such as the pelvis, scapula and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Nitinol bone staple implant of dimensions 20x20x20mm with a 2.0x3.0mm diameter leg/bridge, 1ea pre-loaded staple delivery instrument with lock pin, 1ea 20mm spaced drill guide; 2ea 1.5mm diameter Kirchner wire with protective tips; 2ea 3.0mm Pull Pins; 1ea 3.0mm Drill Bit (color band of purple)
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes
Device Description : Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy Product received FDA 510(k) clearance for: Hand and Foot fragment and osteotomy fixation and joint arthrodesis, fixation of proximal tibial metaphysis osteotomy and adjunctive fixation of small bone fragments (i.e. small fragments of bone that are not comminuted to the extent and preclude staple placement). These fragments may be located in long bones such as the femur, fibula or tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula, and sternum. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol SuperSTEP™ staple implant of dimensions 20 x 20 x 20mm with a 06mm vertical step with a 2.0mm x 3.0mm leg diameter leg/bridge held in the instrument with a locking pin; 1ea 20mm spaced drill guide with step alignment pin, pre-assembled; 2ea 1.5mm diameter Kirchner wire with protective tips; 1 ea 3.0mm Pull Pin, 1ea 3.0mm Drill Bit (color band red).
Device Class : 2
Duns Number: 830255506
Premarket Exempt : No
Prescription Use : Yes