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™ A/R Femoral Nail - B058ART113201 Catalog Number : ART-11-320

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 320mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART113401 Catalog Number : ART-11-340

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 340mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART113601 Catalog Number : ART-11-360

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 360mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART113801 Catalog Number : ART-11-380

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 380mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART114001 Catalog Number : ART-11-400

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 400mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART114201 Catalog Number : ART-11-420

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø11mm x 420mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART123201 Catalog Number : ART-12-320

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 320mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART123401 Catalog Number : ART-12-340

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 340mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART123601 Catalog Number : ART-12-360

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 360mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

Talon™ DistalFix™ A/R Femoral Nail - B058ART123801 Catalog Number : ART-12-380

Device Description : Talon™ DistalFix™ A/R Femoral Nail Ø12mm x 380mm

Device Class : 2

Duns Number: 945518848

Premarket Exempt : No

Product Code : HSB

Prescription Use : Yes

Device Count : 1

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