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 - B528100900001003030 Catalog Number : 1009-0000 1003-03

Device Description : PSE REMOVAL TOOL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101000000 Catalog Number : 1010-0000

Device Description : PSL INSERTER

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101100000 Catalog Number : 1011-0000

Device Description : PSE INSERTER

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101140060 Catalog Number : 1011-4006

Device Description : PSE 6MM X 40MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101140080 Catalog Number : 1011-4008

Device Description : PSE 8MM X 40MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101140100 Catalog Number : 1011-4010

Device Description : PSE 10MM X 40MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101140120 Catalog Number : 1011-4011

Device Description : PSE 12MM X 40MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101145060 Catalog Number : 1011-4506

Device Description : PSE 6MM X 45MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101145080 Catalog Number : 1011-4508

Device Description : PSE 8MM X 45MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528101145100 Catalog Number : 1011-4510

Device Description : PSE 10MM X 45MM TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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