SUMMIT SPINE LLC

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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

Yellowstone - B587XL1824300 Catalog Number : XL182430

Device Description : 18mm H x 24mm W x 30mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182430120 Catalog Number : XL182430-12

Device Description : 18mm H x 24mm W x 30mm L x 12 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL18243080 Catalog Number : XL182430-8

Device Description : 18mm H x 24mm W x 30mm L x 8 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL1824350 Catalog Number : XL182435

Device Description : 18mm H x 24mm W x 35mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182435120 Catalog Number : XL182435-12

Device Description : 18mm H x 24mm W x 35mm L x 12 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL18243580 Catalog Number : XL182435-8

Device Description : 18mm H x 24mm W x 35mm L x 8 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL1824400 Catalog Number : XL182440

Device Description : 18mm H x 24mm W x 40mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182440120 Catalog Number : XL182440-12

Device Description : 18mm H x 24mm W x 40mm L x 12 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL18244080 Catalog Number : XL182440-8

Device Description : 18mm H x 24mm W x 40mm L x 8 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL1824450 Catalog Number : XL182445

Device Description : 18mm H x 24mm W x 45mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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