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 - 00841193100104 Catalog Number : 4222-010

Device Description : EVOS Straight HA PEEK 10mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100111 Catalog Number : 4222-011

Device Description : EVOS Straight HA PEEK 11mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100128 Catalog Number : 4222-012

Device Description : EVOS Straight HA PEEK 12mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100135 Catalog Number : 4222-013

Device Description : EVOS Straight HA PEEK 13mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100142 Catalog Number : 4222-014

Device Description : EVOS Straight HA PEEK 14mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100159 Catalog Number : 4222-015

Device Description : EVOS Straight HA PEEK 15mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100166 Catalog Number : 4222-016

Device Description : EVOS Straight HA PEEK 16mm x 9mm x 22mm Biconvex 0°, Narrow

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100173 Catalog Number : 4123-009

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

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100180 Catalog Number : 4123-010

Device Description : EVOS Straight HA PEEK 10mm x 9mm x 26mm Biconvex 0°, Wide

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100197 Catalog Number : 4123-011

Device Description : EVOS Straight HA PEEK 11mm x 9mm x 26mm Biconvex 0°, Wide

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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