Ascension Orthopedics, Inc.

Address:11101 Metric Blvd,Austin,TX,78758,US

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Device Description : The Integra Total Foot System is a system containing bone plates and screws desi The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The 2-Hole Straight Tarsalis Plate is offered in short and long lengths. The 3-Hole and 10-Hole Straight Plates are included in the system as standard lengths. The 4-Hole Straight Tarsalis Plate is offered in both standard and short lengths. The Crescentic Tarsalis Plate is offered in left and right configurations. The 4-Hole Diamond Plate is available in left and right configurations. The T-Shaped Tarsalis Plates are offered in 4-hole, 5-hole, and 6-hole configurations. The 5-hole designs are provided in straight, left, and right configurations. The 6-hole is only provided in straight configuration. Upon request, the 6-hole, 7-hole and 8-hole T-Shaped Tarsalis Plates are available.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : TFSFOREFTIMP

Device Description : The Integra Total Foot System is a system containing bone plates and screws desi The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The fore foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

- Catalog Number : TFSREARFTIMP

Device Description : The Integra Total Foot System is a system containing bone plates and screws desi The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : The Headed Compression Screw System contains compression screws used with the An The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diameter 4.0mm or 4.5mm

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : The Headed Compression Screw System contains compression screws used with the An The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diamter 6.5mm or 7.5mm.

Device Class :

Duns Number: 942377524

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : The Integra Proximal Humeral Fracture Plate System will be composed of left and The Integra Proximal Humeral Fracture Plate System will be composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The plates and screws are made of 316L Stainless Steel. The GT plate is designed to cover the greater tuberosity and is available in four-hole, seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system will also feature 3.5mm locking screws, non-locking compression screws and non-locking partial thread screws. In addition 2.7mm locking screws are also available. The system is indicated for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Instruments are provided to assist with the implants.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Device Description : The Integra Total Foot System is a system containing bone plates and screws desi The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. . The fore foot and mid foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. Also included are 2.7mm locking screws.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

Device Description : The Integra Total Foot System is a system containing bone plates and screws desi The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The rear foot plates include lapidus plates, interpositioning plates, universal rear foot plates, rear foot reconstruction plates, flat line arthrodesis plates, dwyer displacement plates, calcaneus plates, and fibular plates. Also included are 3.7mm locking screws.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

Device Description : The Integra Spider Limited Wrist Fusion titanium plate includes eight-holes and The Integra Spider Limited Wrist Fusion titanium plate includes eight-holes and can be utilized in various locations throughout the wrist.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

Device Description : The Mini Integra Spider Limited Wrist Fusion titanium plate includes six-holes a The Mini Integra Spider Limited Wrist Fusion titanium plate includes six-holes and can be utilized in various locations throughout the wrist.

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1