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

Screw, Fixation, Bone (HWC) (7) Plate, Fixation, Bone (HRS) (3)

Premarket Exempt

Yes

Clear

RibLoc - 10814493010111 Catalog Number :

Device Description : 12mm x 76mm Rib Plate

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HRS

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010128 Catalog Number :

Device Description : 14mm x 76mm Rib Plate

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HRS

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010135 Catalog Number :

Device Description : 8mm x 2.7mm Primary Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010142 Catalog Number :

Device Description : 10mm x 2.7mm Primary Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010159 Catalog Number :

Device Description : 12mm x 2.7mm Primary Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HRS

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010166 Catalog Number :

Device Description : 14mm x 2.7mm Primary Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010173 Catalog Number :

Device Description : 8mm x 2.3mm Intermediate Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010180 Catalog Number :

Device Description : 10mm x 2.3mm Intermediate Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010197 Catalog Number :

Device Description : 12mm x 2.3mm Intermediate Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

RibLoc - 10814493010203 Catalog Number :

Device Description : 14mm x 2.3mm Intermediate Rib Screw

Device Class : 2

Duns Number: 619225415

Premarket Exempt : Yes

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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