SIG MEDICAL CORP.

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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

Plate, Fixation, Bone (HRS) (10) Screw, Fixation, Bone (HWC) (7)

Premarket Exempt

Clear

AdvantageRib - 00854865007427 Catalog Number : 323.1290

Device Description : AdvantageRib Washer, 9.5mm

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007434 Catalog Number : 323.0055

Device Description : AdvantageRib Folding Clamp

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007441 Catalog Number : 323.0056

Device Description : AdvantageRib Folding Clamp, 4.0 Drill Sleeve

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007489 Catalog Number : 323.1010

Device Description : AdvantageRib Short Bridge and 10mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007496 Catalog Number : 323.1011

Device Description : AdvantageRib Short Bridge and 11mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007502 Catalog Number : 323.1012

Device Description : AdvantageRib Short Bridge and 18mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007519 Catalog Number : 323.1013

Device Description : AdvantageRib Short Bridge and 23mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007526 Catalog Number : 323.1020

Device Description : AdvantageRib Short Bridge and 10mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007533 Catalog Number : 323.1021

Device Description : AdvantageRib Short Bridge and 11mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS, HWC

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007540 Catalog Number : 323.1022

Device Description : AdvantageRib Short Bridge and 18mm Locking Posts

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HWC, HRS

Prescription Use : Yes

Device Count : 1

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