Cutting Edge Spine, LLC

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

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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

No Yes

Clear

EVOS Lumbar Interbody System - 00841193100319 Catalog Number : 4023-015

Device Description : EVOS Straight HA PEEK 15mm x 9mm x 26mm Biconvex 0°, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100326 Catalog Number : 4023-016

Device Description : EVOS Straight HA PEEK 16mm x 9mm x 26mm Biconvex 0°, Standard

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100340 Catalog Number : 4474-010

Device Description : EVOS Rotate HA PEEK 10mm x 8mm x 22mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100357 Catalog Number : 4474-011

Device Description : EVOS Rotate HA PEEK 11mm x 8mm x 22mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100364 Catalog Number : 4484-011

Device Description : EVOS Rotate HA PEEK 11mm x 8mm x 26mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100371 Catalog Number : 4475-010

Device Description : EVOS Rotate HA PEEK 10mm x 9mm x 22mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100388 Catalog Number : 4475-011

Device Description : EVOS Rotate HA PEEK 11mm x 9mm x 22mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100395 Catalog Number : 4475-012

Device Description : EVOS Rotate HA PEEK 12mm x 9mm x 22mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100401 Catalog Number : 4486-011

Device Description : EVOS Rotate HA PEEK 11mm x 9mm x 26mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100418 Catalog Number : 4486-012

Device Description : EVOS Rotate HA PEEK 12mm x 9mm x 26mm Biconvex, 5°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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