Cutting Edge Spine, LLC

Address:6012 Waxhaw Highway,Mineral Spgs,NC,28108,US

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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

Yes No

Clear

EVOS Lumbar Interbody System - 00841193100524 Catalog Number : 4012-009

Device Description : EVOS Straight HA PEEK, 9mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100531 Catalog Number : 4012-010

Device Description : EVOS Straight HA PEEK, 10mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100548 Catalog Number : 4012-011

Device Description : EVOS Straight HA PEEK, 11mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100555 Catalog Number : 4012-012

Device Description : EVOS Straight HA PEEK, 12mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100562 Catalog Number : 4012-013

Device Description : EVOS Straight HA PEEK, 13mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100579 Catalog Number : 4012-014

Device Description : EVOS Straight HA PEEK, 14mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100586 Catalog Number : 4012-015

Device Description : EVOS Straight HA PEEK, 15mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100593 Catalog Number : 4012-016

Device Description : EVOS Straight HA PEEK, 16mm x 8mm x 22mm, Flat 5 °, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100609 Catalog Number : 4212-007

Device Description : EVOS Straight HA PEEK, 7mm x 8mm x 22mm, Flat 5 °, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100616 Catalog Number : 4212-008

Device Description : EVOS Straight HA PEEK, 8mm x 8mm x 22mm, Flat 5 °, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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