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

Intervertebral fusion device with integrated fixation, lumbar (OVD) (4) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (4) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (1) RONGEUR (HTX) (1)

Premarket Exempt

No Yes

Clear

ALPHATEC SOLUS - 00844856099142 Catalog Number :

Device Description : ALPHATEC SOLUS LUMBAR SPACER, 12mm LARGE, 12 LORDOTIC, STERILE

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ALPHATEC SOLUS - 00844856099159 Catalog Number :

Device Description : ALPHATEC SOLUS LUMBAR SPACER, 14mm LARGE, 12 LORDOTIC, STERILE

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ALPHATEC SOLUS - 00844856099166 Catalog Number :

Device Description : ALPHATEC SOLUS LUMBAR SPACER, 16mm LARGE, 12 LORDOTIC, STERILE

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

ALPHATEC SOLUS - 00844856099173 Catalog Number :

Device Description : ALPHATEC SOLUS LUMBAR SPACER, 18mm LARGE, 12 LORDOTIC, STERILE

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

TRESTLE ANTERIOR CERVICAL PLATING SYSTEM - 00844856099210 Catalog Number :

Device Description : ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35

Device Class : 2

Duns Number: 602465783

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Xenon - 03661380022579 Catalog Number :

Device Description : Persuader

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : HTX

Prescription Use : Yes

Device Count : 1

Isobar - 03661380024108 Catalog Number :

Device Description : Axial Persuader

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380024184 Catalog Number :

Device Description : Extension head breaker

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Xenon - 03661380024207 Catalog Number :

Device Description : Counter torque

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Isobar - 03661380024214 Catalog Number :

Device Description : Reduction Screw Tab Ring

Device Class : 1

Duns Number: 602465783

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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