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) (8)

Premarket Exempt

Clear

Yellowstone - B587XL18246080 Catalog Number : XL182460-8

Device Description : 18mm H x 24mm W x 60mm 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 - B587XL1824650 Catalog Number : XL182465

Device Description : 18mm H x 24mm W x 65mm L Lateral Implant

Device Class : 2

Duns Number: 079539689

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Yellowstone - B587XL182465120 Catalog Number : XL182465-12

Device Description : 18mm H x 24mm W x 65mm 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 - B587XL18246580 Catalog Number : XL182465-8

Device Description : 18mm H x 24mm 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 - B587XL1824700 Catalog Number : XL182470

Device Description : 18mm H x 24mm 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 - B587XL182470120 Catalog Number : XL182470-12

Device Description : 18mm H x 24mm 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 - B587XL18247080 Catalog Number : XL182470-8

Device Description : 18mm H x 24mm 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 - B597XL16142580 Catalog Number : XL161425-8

Device Description : 16mm H x 14mm W x 25mm L 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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