ACUTE INNOVATIONS LLC

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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 (KTT) (2) Cerclage, Fixation (JDQ) (2) Plate, Fixation, Bone (HRS) (2) Screw, Fixation, Bone (HWC) (2)

Premarket Exempt

Yes

Clear

BioBridge - 10814493010609 Catalog Number :

Device Description : 18 Hole Resorbable Rib Plate

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AcuTie II - 10814493010661 Catalog Number :

Device Description : AcuTie Two Sternum Plate

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC, JDQ, KTT

Prescription Use : Yes

Device Count : 1

AcuTie - 10814493010753 Catalog Number :

Device Description : AcuTie Sternum Plate

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : KTT, JDQ, HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010760 Catalog Number :

Device Description : 126mm Straight Plate

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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