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 - B587XL18226580 Catalog Number : XL182265-8

Device Description : 18mm H x 22mm W x 65mm 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 - B587XL1822700 Catalog Number : XL182270

Device Description : 18mm H x 22mm W x 70mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182270120 Catalog Number : XL182270-12

Device Description : 18mm H x 22mm W x 70mm 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 - B587XL18227080 Catalog Number : XL182270-8

Device Description : 18mm H x 22mm W x 70mm 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 - B587XL1824200 Catalog Number : XL18240

Device Description : 18mm H x 24mm W x 20mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182420120 Catalog Number : XL182420-12

Device Description : 18mm H x 24mm W x 20mm 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 - B587XL18242080 Catalog Number : XL182420-8

Device Description : 18mm H x 24mm W x 20mm 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 - B587XL1824250 Catalog Number : XL182425

Device Description : 18mm H x 24mm W x 25mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182425120 Catalog Number : XL182425-12

Device Description : 18mm H x 24mm W x 25mm 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 - B587XL18242580 Catalog Number : XL182425-8

Device Description : 18mm H x 24mm W x 25mm L x 8 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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