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 - B587XL1822350 Catalog Number : XL182235

Device Description : 18mm H x 22mm 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 - B587XL182235120 Catalog Number : XL182235-12

Device Description : 18mm H x 22mm 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 - B587XL18223580 Catalog Number : XL182235-8

Device Description : 18mm H x 22mm 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 - B587XL1822400 Catalog Number : XL182240

Device Description : 18mm H x 22mm 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 - B587XL182240120 Catalog Number : XL182240-12

Device Description : 18mm H x 22mm 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 - B587XL18224080 Catalog Number : XL182240-8

Device Description : 18mm H x 22mm 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 - B587XL1822450 Catalog Number : XL182245

Device Description : 18mm H x 22mm W x 45mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182245120 Catalog Number : XL182245-12

Device Description : 18mm H x 22mm 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 - B587XL18224580 Catalog Number : XL182245-8

Device Description : 18mm H x 22mm 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 - B587XL1822500 Catalog Number : XL182250

Device Description : 18mm H x 22mm W x 50mm 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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