PANTHEON SPINAL, LLC

Address:40132 Industrial Park Circle,Georgetown,TX,78626,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 Bone Graft, Lumbar (MAX) (10)

Premarket Exempt

Clear

EPIPHANY - B528101145120 Catalog Number : 1011-4512

Device Description : PSE 12MM X 45MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101200000 Catalog Number : 1012-0000

Device Description : A-LIFT INSERTER

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101603010 Catalog Number : 1016-0301

Device Description : 3MM X 12 IN STRAIGHT PITUITARY RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101603020 Catalog Number : 1016-0302

Device Description : 3MM X 12 IN ANGLE LET PITUITARY RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101603030 Catalog Number : 1016-0303

Device Description : 3MM X 12 IN ANGLE RT PITUITARY RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101605010 Catalog Number : 1016-0501

Device Description : 5MM X 12 IN STRAIGHT PITUITARY RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101605020 Catalog Number : 1016-0502

Device Description : 5MM X 12 IN ANGLE LT PITUITARY RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101605030 Catalog Number : 1016-0503

Device Description : 5MM X 12 IN ANGLE RT PITUITARY RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101707010 Catalog Number : 1017-0701

Device Description : 7MM OSTEOPHYTE BITER RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101707020 Catalog Number : 1017-0702

Device Description : 7MM OSTEOPHYTE ANGLE LT RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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