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

Staple, Fixation, Bone (JDR) (10)

Premarket Exempt

No Yes

Clear

Stealthfix Intraosseous Fixation System - 00810082893984 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 15mm 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 - 00810082893991 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 15mm 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 - 00810082894004 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 15mm 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 - 00810082894011 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 15mm 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 - 00810082894028 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 14mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894035 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 16mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894042 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 18mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894059 Catalog Number :

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

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894066 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 22mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082894073 Catalog Number :

Device Description : StealthFix Ti Implant 4.5mm Post x 20mm Span x 24mm Long

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

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