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

T-FIX™3Dsi Joint Fusion System - 00841193125749 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 65, Fully 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 - 00841193125756 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 11.5 x 70, Fully 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 - 00841193125763 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13 x 25, Fully 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 - 00841193125770 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 30, Fully 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 - 00841193125787 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 35, Fully 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 - 00841193125794 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 40, Fully 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 - 00841193125800 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 45, Fully 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 - 00841193125817 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 50, Fully 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 - 00841193125824 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 55, Fully 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 - 00841193125831 Catalog Number :

Device Description : T-FIX™ 3DSI Screw, 13.0 x 60, Fully 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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