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 - B528100122021022190 Catalog Number : 1001-2202 1022-19

Device Description : 22MM 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 - B528100122031022200 Catalog Number : 1001-2203 1022-20

Device Description : 22MM 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 - B528100122041022210 Catalog Number : 1001-2204 1022-21

Device Description : 22MM 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 - B528100122070 Catalog Number : 1001-2207

Device Description : 22MM CURVED 30 DEGREE RIGHT COBB SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100122080 Catalog Number : 1001-2208

Device Description : 22MM 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 - B528100202011022010 Catalog Number : 1002-0201 1022-01

Device Description : #2 STRAIGHT CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528100202021022020 Catalog Number : 1002-0202 1022-02

Device Description : #2 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 - B528100202030 Catalog Number : 1002-0203

Device Description : #2 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 - B528100202040 Catalog Number : 1002-0204

Device Description : #2 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 - B528100202050 Catalog Number : 1002-0205

Device Description : #2 30 DEGREE CURVED RIGHT CURETTE SHAFT

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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