A.M. SURGICAL, INC.

Address:285 MIDDLE COUNTRY RD SUITE 206,SMITHTOWN,NY,11787,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

Pin, Fixation, Smooth (HTY) (6) Accessories, Arthroscopic (NBH) (2) Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite (LXT) (2)

Premarket Exempt

No Yes

Clear

CPX - 00857915007002 Catalog Number :

Device Description : Titanium CPX

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

CFCPX - 00857915007019 Catalog Number :

Device Description : Carbon Fiber CPX

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : LXT

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007057 Catalog Number :

Device Description : One 40mm x 1.6mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007064 Catalog Number :

Device Description : One 45mm x 1.6mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007071 Catalog Number :

Device Description : One 50mm x 1.6mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007088 Catalog Number :

Device Description : One 55mm x 1.6mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007095 Catalog Number :

Device Description : One 60mm x 1.6mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007125 Catalog Number :

Device Description : IM Nail Combo Kit

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Stratos - 00857915007132 Catalog Number :

Device Description : Endoscopic Release System

Device Class :

Duns Number: 160020087

Premarket Exempt : Yes

Product Code : NBH

Prescription Use : Yes

Device Count : 1

EndoSleeve - 00857915007149 Catalog Number :

Device Description : EndoSleeve Soft Tissue Release System

Device Class :

Duns Number: 160020087

Premarket Exempt : Yes

Product Code : NBH

Prescription Use : Yes

Device Count : 1

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