Altus Spine, LLC

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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

Spinal vertebral body replacement device (MQP) (8)

Premarket Exempt

No Yes

Clear

PEEK Interbody Fusion System - B417TL220061 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 6mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220071 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 7mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220081 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 8mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220091 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 9mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220101 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 10mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220111 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 11mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220121 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 12mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

PEEK Interbody Fusion System - B417TL220131 Catalog Number :

Device Description : PEEK, TLIF, 22x11, 13mm, 0degree

Device Class :

Duns Number: 078331322

Premarket Exempt : No

Product Code : MQP

Prescription Use : Yes

Device Count : 1

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