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

INSTRUMENT, CUTTING, ORTHOPEDIC (HTZ) (5) Intervertebral fusion device with bone graft, lumbar (MAX) (2) Intervertebral fusion device with bone graft, thoracic (PHM) (2) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1) PROBE (HXB) (1) TAP, BONE (HWX) (1)

Premarket Exempt

No Yes

Clear

Aspida - 00190376000039 Catalog Number :

Device Description : Aspida Stab and Grab Inserter 2.0

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000046 Catalog Number :

Device Description : Lateral Rotating Disc Cutters, 6mm

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTZ

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000053 Catalog Number :

Device Description : Lateral Rotating Disc Cutters, 8mm

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTZ

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000060 Catalog Number :

Device Description : Lateral Rotating Disc Cutters, 10mm

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTZ

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000077 Catalog Number :

Device Description : Lateral Rotating Disc Cutters, 12mm

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTZ

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000084 Catalog Number :

Device Description : Lateral Rotating Disc Cutters, 14mm

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTZ

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000138 Catalog Number :

Device Description : Ball Tip Probe, Laser Marked

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HXB

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000145 Catalog Number :

Device Description : CBx Tap, Narrow Shaft, 4.5mm

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000152 Catalog Number :

Device Description : C-C Angled ALIF TRIAL, 6 x 34 x 24 mm, 20°

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : PHM, MAX

Prescription Use : Yes

Device Count : 1

General Instruments - 00190376000169 Catalog Number :

Device Description : C-C Angled ALIF TRIAL, 9 x 38 x 28 mm, 15°

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : MAX, PHM

Prescription Use : Yes

Device Count : 1

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