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 - B28101812010 Catalog Number : 1018-1201

Device Description : Fraizer Suction Tube 12 FR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B518LPSL55241270 Catalog Number : LPSL 55-24-12-7

Device Description : Spann LLIF Cage 55x24x12mm 7 degrees

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B527PSL452414120 Catalog Number : PSL 45-24-14-12

Device Description : Spann LLIF Cage 45x24x14mm 12 degrees

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100118011022130 Catalog Number : 1001-1801 1022-13

Device Description : 18MM STRAIGHT COBB

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100118021022140 Catalog Number : 1001-1802 1022-14

Device Description : 18MM CURVED 30 DEGREE DOWN COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100118031022150 Catalog Number : 1001-1803 1022-15

Device Description : 18MM CURVED 15 DEGREE UP COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100118041022160 Catalog Number : 1001-1804 1022-16

Device Description : 18MM CURVED 15 DEGREE DOWN COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100118070 Catalog Number : 1001-1807

Device Description : 18MM CURVED 30 DEGREES RIGHT COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100118080 Catalog Number : 1001-1808

Device Description : 18MM CURVED 30 DEGREE LEFT COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100122011022180 Catalog Number : 1001-2201 1022-18

Device Description : 22MM STRAIGHT COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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