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 - B528101707030 Catalog Number : 1017-0703

Device Description : 7MM OSTEOPHYTE ANGLE RT RONGEUR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528101810010 Catalog Number : 1018-1001

Device Description : Fraizer Suction Tube 10 FR

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528101900000 Catalog Number : 1019-0000

Device Description : Bayonet Bipolor Forcep

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528102004000 Catalog Number : 1020-0400

Device Description : Bayonet Penfield #4

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528102100000 Catalog Number : 1021-0000

Device Description : Nerve root retractor

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Epiphany - B528102200000 Catalog Number : 1022-0000

Device Description : Bayonet Anulus Cutting Knife

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528102706000 Catalog Number : 1027-0600

Device Description : 6MM STRAIGHT TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528102708000 Catalog Number : 1027-0800

Device Description : 8MM STRAIGHT TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528102710000 Catalog Number : 1027-1000

Device Description : 10MM STRAIGHT TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EPIPHANY - B528102712000 Catalog Number : 1027-1200

Device Description : 12MM STRAIGHT TRIAL

Device Class : 2

Duns Number: 071012634

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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