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) (2)

Premarket Exempt

No Yes

Clear

EVOL®SI Joint Fusion System - 00841193100425 Catalog Number : CES-284

Device Description : EVOL®SI, 2.4mm x 350mm Sharp, Short K-Wire

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100432 Catalog Number : CES-285

Device Description : EVOL®SI, 2.4mm x 480mm Sharp, Long K-Wire

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100449 Catalog Number : CES-286

Device Description : EVOL®SI, 2.4mm x 480mm Blunt, Long K-Wire

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100456 Catalog Number : CES-287

Device Description : EVOL®SI, Fixed Wire Guide, 14mm

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100463 Catalog Number : CES-288

Device Description : EVOL®SI, Fixed Wire Guide, 17mm

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100470 Catalog Number : CES-289

Device Description : EVOL®SI, Fixed Wire Guide, 20mm

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100487 Catalog Number : CES-290

Device Description : EVOL®SI, Adjustable Wire Guide

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOL®SI Joint Fusion System - 00841193100494 Catalog Number : CES-290-02

Device Description : EVOLSI, Variable Wire Guide (2nd Post)

Device Class :

Duns Number: 069472647

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

EVOS Lumbar Interbody System - 00841193100500 Catalog Number : 4012-007

Device Description : EVOS Straight HA PEEK, 7mm 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 - 00841193100517 Catalog Number : 4012-008

Device Description : EVOS Straight HA PEEK, 8mm 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

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