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Icotec

Last updated May 24, 2026

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Country: US
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Catalogue (485)

Page 2 of 10

Device	Model / Reference	Registries	Class	Status
KONG-C VBR, End Plate & Screw, 6° / 14 x 13 mm	12-80-601413	FDA UDI	Class II	Active
KONG-TL VBR System, Implant Assembly Plate	44-020	FDA UDI	Class II	Active
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container Inla	42-700-3	FDA UDI	Class II	Active
KONG-C VBR M, Body, 32 mm	12-80-1332-0	FDA UDI	Class II	Active
KONG-C VBR M, Body, 66 mm	12-80-1366-0	FDA UDI	Class II	Active
KONG-C VBR System, Trial Body, 26 mm	43-226	FDA UDI	Class II	Active
VADER Pedicle System VADER Pedicle System MIS 2/2 Container Base	42-863-1	FDA UDI	Class II	Active
KONG-TL VBR System, KONG-TL VBR E, Container Inlay	44-090-3	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Ti, Curved, Ø 6.0 r120 x 90 mm	16-60-81209	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 11 x 12 mm	12-57-12-32-11-ITi	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm	16-60-71203	FDA UDI	Class II	Active
KONG-TL VBR System, Adapter for Expansion Handle	44-077	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Ti, Curved, Ø 6.0 r120 x 100 mm	16-60-81210	FDA UDI	Class II	Active
icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm	16-6022-98545	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, J-Rod, Ø 6.0 r000 + r450 x 60/80 mm	16-60-70608-9	FDA UDI	Class II	Active
icotec Cervical Cage, Cervical Cage Anatomic, Container, complete	41-12	FDA UDI	Class II	Active
LightMore Pedicle System 6.0, Screw, Carbon/PEEK, Polyax., Noncann., Ø 5.5 x 40	16-6024-55540	FDA UDI	Class II	Active
icotec Spine System, Emerg. Screw Self-Tap, Ø 4.25 x 15 mm	12-70-42-153	FDA UDI	Class II	Active
icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm	13-59-42511	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 11 x 16 mm	13-58-16-32-11-ITi	FDA UDI	Class II	Active
KONG-C VBR M, Body, 40 mm	12-80-1340-0	FDA UDI	Class II	Active
VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm	42-542-1	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 8 x 16 mm	13-58-16-32-08-ITi	FDA UDI	Class II	Active
VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Lid	42-890-2	FDA UDI	Class II	Active
KONG-C VBR System, Trial Body, 46 mm	43-246	FDA UDI	Class II	Active
KONG-C VBR System, Inserter Sleeve	43-010	FDA UDI	Class II	Active
icotec Cervical Cage Anatomic 7 x 13 mm	13-41-0713	FDA UDI	Class II	Active
icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 50 mm	16-6022-98550	FDA UDI	Class II	Active
KONG-TL VBR, End Plate, rectangular, M and Screw, 4° x 33 mm	12-90-043320	FDA UDI	Class II	Active
KONG-TL VBR System, Holding Sleeve	44-010-01	FDA UDI	Class II	Active
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm	16-60-74503	FDA UDI	Class II	Active
icotec Pedicle System 6.0, Rod, Ti, Curved, Ø 6.0 r120 x 070 mm	16-60-91207	FDA UDI	Class II	Active
VADER Pedicle System, Template for R120 & R450 curved rods	42-897	FDA UDI	Class II	Active
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 60 mm	16-6023-55560	FDA UDI	Class II	Active
VADER Pedicle System, Cannulated Tap MIS, Ø 7.5 mm	42-642	FDA UDI	Class II	Active
icotec Systems, Deburring tool	42-894	FDA UDI	Class II	Active
KONG-TL VBR, End Plate, rectangular, XL and Screw, 12° x 52 mm	12-90-125220	FDA UDI	Class II	Active
KONG-C VBR, End Plate & Screw, 0° / 18 x 14 mm	12-80-001814	FDA UDI	Class II	Active
KONG-TL VBR System, Revision Forceps	44-076	FDA UDI	Class II	Active
VADER Pedicle System, VADER Pedicle System Rod-2-size, Container, complete	42-890	FDA UDI	Class II	Active
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container Base	42-700-1	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 14 x 12 mm	12-57-12-32-14-ITi	FDA UDI	Class II	Active
VADER Pedicle System, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm	16-6023-98545	FDA UDI	Class II	Active
icotec Lumbar Cage PLIF 8° / 25 mm x 14 mm	13-59-82514	FDA UDI	Class II	Active
icotec Systems, Navigation Adapter	42-680N	FDA UDI	Class II	Active
VADER Pedicle System, K-wire, Ø 1.1 × 472 mm	42-541	FDA UDI	Class II	Active
icotec Pedicle System, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm	16-6023-98540	FDA UDI	Class II	Active
KONG-TL VBR System, KONG-TL VBR, E, Container Inlay	44-080-3	FDA UDI	Class II	Active
icotec Lumbar Cage ETurn TLIF 12 x 16 mm	13-58-16-32-12-ITi	FDA UDI	Class II	Active
KONG-TL VBR, End Plate, round, S and Screw, 0° x 26 mm	12-90-0026	FDA UDI	Class II	Active

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