Nextremity Solutions, Inc.

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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) (8) Orthopedic Manual Surgical Instrument (LXH) (1) Staple, Fixation, Bone (JDR) (1)

Premarket Exempt

No Yes

Clear

Stealthfix Intraosseous Fixation System - 00810082894189 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 28mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894196 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 30mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894202 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 32mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894219 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 34mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894226 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 36mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894233 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 38mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896060 Catalog Number :

Device Description : StealthFix Targeting Guide Shallow

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896077 Catalog Number :

Device Description : StealthFix Targeting Guide Deep

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896091 Catalog Number :

Device Description : StealthFix Impactor Long Handle

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896114 Catalog Number :

Device Description : StealthFix Inserter 3.5mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

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