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 - 00841193100005 Catalog Number : 4069-009

Device Description : EVOS Curved HA PEEK 9mm x 9mm x 30 mm, Biconvex 6 °

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100012 Catalog Number : 4071-009

Device Description : EVOS Curved HA PEEK 9mm x 10mm x 30 mm,Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100029 Catalog Number : 4071-010

Device Description : EVOS Curved HA PEEK 10mm x 10mm x 30mm, Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100036 Catalog Number : 4071-011

Device Description : EVOS Curved HA PEEK 11mm x 10mm x 30 mm,Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100043 Catalog Number : 4071-012

Device Description : EVOS Curved HA PEEK 12mm x 10mm x 30 mm,Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100050 Catalog Number : 4071-013

Device Description : EVOS Curved HA PEEK 13mm x 10mm x 30 mm,Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100067 Catalog Number : 4071-014

Device Description : EVOS Curved HA PEEK 14mm x 10mm x 30 mm,Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100074 Catalog Number : 4071-015

Device Description : EVOS Curved HA PEEK 15mm x 10mm x 30 mm,Biconvex 6°

Device Class : 2

Duns Number: 069472647

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

EVOS Lumbar Interbody System - 00841193100081 Catalog Number : 4222-008

Device Description : EVOS Straight HA PEEK 8mm 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 - 00841193100098 Catalog Number : 4222-009

Device Description : EVOS Straight HA PEEK 9mm 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

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