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 - B528100207020 Catalog Number : 1002-0702

Device Description : 7MM ANGLED BOX CURETTE

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B528100213010 Catalog Number : 1002-1301

Device Description : 13mm End Plate Scraper

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528100213020 Catalog Number : 1002-1302

Device Description : 13mm Angled End Plate Scraper

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528100310011022110 Catalog Number : 1003-1001 1022-11

Device Description : Straight Osteotome Shaft 10mm

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528100310021022120 Catalog Number : 1003-1002 1022-12

Device Description : Curved Osteotome Shaft 10mm

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100418011023010 Catalog Number : 1004-1801 1023-01

Device Description : STRAIGHT RASP 18MM

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100418021023020 Catalog Number : 1004-1802 1023-02

Device Description : CURVED 15 DEGREE UP/DOWN RASP 18MM

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100418041023040 Catalog Number : 1004-1804 1023-04

Device Description : CURVED RT/LT RASP 18MM

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100700000 Catalog Number : 1007-0000

Device Description : SLAP HAMMER

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100800001003020 Catalog Number : 1008-0000 1003-02

Device Description : PSE REMOVAL TOOL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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