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 - B587XL182445120 Catalog Number : XL182445-12

Device Description : 18mm H x 24mm W x 45mm 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 - B587XL18244580 Catalog Number : XL182445-8

Device Description : 18mm H x 24mm W x 45mm 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 - B587XL1824500 Catalog Number : XL182450

Device Description : 18mm H x 24mm W x 50mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182450120 Catalog Number : XL182450-12

Device Description : 18mm H x 24mm W x 50mm 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 - B587XL18245080 Catalog Number : XL182450-8

Device Description : 18mm H x 24mm W x 50mm 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 - B587XL1824550 Catalog Number : XL182455

Device Description : 18mm H x 24mm W x 55mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182455120 Catalog Number : XL182455-12

Device Description : 18mm H x 24mm W x 55mm 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 - B587XL18245580 Catalog Number : XL182455-8

Device Description : 18mm H x 24mm W x 55mm 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 - B587XL1824600 Catalog Number : XL182460

Device Description : 18mm H x 24mm W x 60mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182460120 Catalog Number : XL182460-12

Device Description : 18mm H x 24mm W x 60mm L x 12 degree Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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