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

Sacroiliac Joint Fixation (OUR) (10)

Premarket Exempt

Yes No

Clear

EVOL®SI Joint Fusion System - 00841193124957 Catalog Number :

Device Description : 11.5mm x 050mm EVOL®SI Screw, 3.2

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

EVOL®SI Joint Fusion System - 00841193124964 Catalog Number :

Device Description : 11.5mm x 055mm EVOL®SI Screw, 3.2

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

EVOL®SI Joint Fusion System - 00841193124971 Catalog Number :

Device Description : 11.5mm x 060mm EVOL®SI Screw, 3.2

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

EVOL®SI Joint Fusion System - 00841193125107 Catalog Number :

Device Description : EVOL®SI Screw Driver, T-40 Cannulated, 3.2

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

T-FIX™3Dsi Joint Fusion System - 00841193125305 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 30, Partially Threaded, HA-nano

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

T-FIX™3Dsi Joint Fusion System - 00841193125312 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 35, Partially Threaded, HA-nano

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

T-FIX™3Dsi Joint Fusion System - 00841193125329 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 40, Partially Threaded, HA-nano

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

T-FIX™3Dsi Joint Fusion System - 00841193125336 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 45, Partially Threaded, HA-nano

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

T-FIX™3Dsi Joint Fusion System - 00841193125343 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 50, Partially Threaded, HA-nano

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

T-FIX™3Dsi Joint Fusion System - 00841193125350 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 55, Partially Threaded, HA-nano

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : OUR

Prescription Use : Yes

Device Count : 1

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