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

Screw, Fixation, Bone (HWC) (6) Pin, Fixation, Smooth (HTY) (3) Accessories, Arthroscopic (NBH) (1)

Premarket Exempt

No Yes

Clear

Ultra - 00857915007170 Catalog Number :

Device Description : Ultra Endoscopic Release System

Device Class : 1

Duns Number: 160020087

Premarket Exempt : Yes

Product Code : NBH

Prescription Use : Yes

Device Count : 1

Secure Screw 40mm - 00857915007194 Catalog Number :

Device Description : Secure Screw 40mm

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Secure Screw 45mm - 00857915007200 Catalog Number :

Device Description : Secure Screw 45mm

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Secure Screw 50mm - 00857915007217 Catalog Number :

Device Description : Secure Screw 50mm

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Secure Screw 55mm - 00857915007224 Catalog Number :

Device Description : Secure Screw 55mm

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Secure Screw 60mm - 00857915007231 Catalog Number :

Device Description : Secure Screw 60mm

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Secure Screw Starter Pack - 00857915007262 Catalog Number :

Device Description : Secure Screw Starter Pack

Device Class : 2

Duns Number: 160020087

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

Secure IM Nail - 00857915007286 Catalog Number :

Device Description : One 65mm 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 - 00857915007293 Catalog Number :

Device Description : One 70mm 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 - 00857915007309 Catalog Number :

Device Description : One 30mm x 1.2mm IM Nail

Device Class :

Duns Number: 160020087

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

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