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) (6) Staple, Fixation, Bone (JDR) (4)

Premarket Exempt

No Yes

Clear

Stealthfix Intraosseous Fixation System - 00810082894080 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 26mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894097 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 28mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894103 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 30mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894110 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 32mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894127 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 16mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894134 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 18mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894141 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 20mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894158 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 22mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894165 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 24mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894172 Catalog Number :

Device Description : StealthFix Lag Screw 3.5mm x 26mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : HWC

Prescription Use : No

Device Count : 1

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