ALPHATEC SPINE, INC.

Address:4101 Willow Lake Blvd.,Memphis,TN,38118,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

Orthopedic stereotaxic instrument (OLO) (6) BIT, DRILL (HTW) (4)

Premarket Exempt

No Yes

Clear

Alphatec Navigation Instrument - 00190376003337 Catalog Number :

Device Description : Cannulated Polyaxial Screw Driver, NI

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003344 Catalog Number :

Device Description : 3.0 mm Cannulated Drill, NI

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003368 Catalog Number :

Device Description : 3.5 mm Cannulated Drill, NI

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003382 Catalog Number :

Device Description : 4.0 mm Cannulated Drill, NI

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003405 Catalog Number :

Device Description : 4.5 mm Cannulated Drill, NI

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003429 Catalog Number :

Device Description : 4.3mm TAP, NI

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003443 Catalog Number :

Device Description : 4.5 mm Tap, NI

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003467 Catalog Number :

Device Description : 5.0 mm Tap, NI

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003481 Catalog Number :

Device Description : 5.5 mm Tap, NI

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

Arsenal - 00190376003504 Catalog Number :

Device Description : 6.0 mm Tap, NI

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

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