Orthopedic Designs North America, Inc.

Address:5912 Breckenridge Parkway,Tampa,FL,33610,US

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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

Rod, Fixation, Intramedullary And Accessories (HSB) (10)

Premarket Exempt

No Yes

Clear

Talon™ DistalFix™ HTN End Cap Locking - B058HTN10C05L1 Catalog Number : HTN-10-C05-L

Device Description : Talon™ DistalFix™ HTN End Cap Locking 10mm x 5mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ HTN End Cap - B058HTN10C101 Catalog Number : HTN-10-C10

Device Description : Talon™ DistalFix™ HTN End Cap 10mm x 10mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ HTN End Cap Locking - B058HTN10C10L1 Catalog Number : HTN-10-C10-L

Device Description : Talon™ DistalFix™ HTN End Cap Locking 10mm x 10mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ HTN End Cap - B058HTN10C151 Catalog Number : HTN-10-C15

Device Description : Talon™ DistalFix™ HTN End Cap 10mm x 15mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ HTN End Cap Locking - B058HTN10C15L1 Catalog Number : HTN-10-C15-L

Device Description : Talon™ DistalFix™ HTN End Cap Locking 10mm x 15mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ Humeral Nail - B058HTN4081651 Catalog Number : HTN-408-165

Device Description : Talon™ DistalFix™ Humeral Nail 4° Ø8mm 165mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ Humeral Nail - B058HTN4081801 Catalog Number : HTN-408-180

Device Description : Talon™ DistalFix™ Humeral Nail 4° Ø8mm 180mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ Humeral Nail - B058HTN4081951 Catalog Number : HTN-408-195

Device Description : Talon™ DistalFix™ Humeral Nail 4° Ø8mm 195mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ Humeral Nail - B058HTN4082101 Catalog Number : HTN-408-210

Device Description : Talon™ DistalFix™ Humeral Nail 4° Ø8mm 210mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ Humeral Nail - B058HTN4082251 Catalog Number : HTN-408-225

Device Description : Talon™ DistalFix™ Humeral Nail 4° Ø8mm 225mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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