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 - B528100204011022030 Catalog Number : 1002-0401 1022-03

Device Description : #4 STRAIGHT CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100204021022040 Catalog Number : 1002-0402 1022-04

Device Description : #4 40 DEGREE CURVED UP CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100204031022050 Catalog Number : 1002-0403 1022-05

Device Description : #4 15 DEGREE CURVED UP CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100204041022060 Catalog Number : 1002-0404 1022-06

Device Description : #4 15 DEGREE CURVED DOWN CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100204050 Catalog Number : 1002-0405

Device Description : #4 90 DEGREE DOWN PUSHER CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100204060 Catalog Number : 1002-0406

Device Description : #4 30 DEGREE CURVED RIGHT CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100204070 Catalog Number : 1002-0407

Device Description : #4 30 DEGREE CURVED LEFT CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100206011022070 Catalog Number : 1002-0601 1022-07

Device Description : #6 STRAIGHT CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100206021022080 Catalog Number : 1002-0602 1022-08

Device Description : #6 40 DEGREE CURVED UP CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100207010 Catalog Number : 1002-0701

Device Description : 7MM STRAIGHT BOX CURETTE

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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