Ascension Orthopedics, Inc.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (LXT) (8) Plate, Fixation, Bone (HRS) (8) Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained (LZJ) (2)

Premarket Exempt

Yes No

Clear

Integra® Total Wrist Fusion System - 10381780065319 Catalog Number : 303314

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065326 Catalog Number : 303316

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065333 Catalog Number : 303318

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065340 Catalog Number : 303320

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065357 Catalog Number : 303322

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065364 Catalog Number : 303324

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065371 Catalog Number : 303326

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : HRS, LXT

Prescription Use : Yes

Device Count : 1

Integra® Total Wrist Fusion System - 10381780065388 Catalog Number : 303328

Device Description : Total Wrist Fusion cortical screw

Device Class : 2

Duns Number: 942377524

Premarket Exempt : No

Product Code : LXT, HRS

Prescription Use : Yes

Device Count : 1

KGTI™ Kinetik Great Toe Implant System - 10381780065395 Catalog Number : 012002

Device Description : The KGTI metatarsal implant is spherical and extends from the plantar base of th The KGTI metatarsal implant is spherical and extends from the plantar base of the metatarsal head dorsally. The implant is fixed by means of a stem, which is inserted into the metatarsal intramedullary canal. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.

Device Class : U

Duns Number: 942377524

Premarket Exempt : No

Product Code : LZJ

Prescription Use : Yes

Device Count : 1

KGTI™ Kinetik Great Toe Implant System - 10381780065401 Catalog Number : 012003

Device Class : U

Duns Number: 942377524

Premarket Exempt : No

Product Code : LZJ

Prescription Use : Yes

Device Count : 1

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