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WILTROM INC.

US

Last updated September 17, 2026

Information

Country
US
Address
2880 Zanker Road, Suite 103, San Jose, CA, 95134
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3014387294
DUNS Number
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Catalogue (561)

Page 2 of 12
DeviceModel / ReferenceRegistriesClassStatus
Wiltrom Spinal Fixation System 43587050 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.0 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41004070 Rod with Taper Tip and Grooved End ø=5.5 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43527540 Polyaxial Pedicle Screw, Cannulated ø=7.5 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43536555 Polyaxial Pedicle Screw ø=6.5 L=55
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002100 Rod with Taper Tips, Pre-bent ø=5.5 L=100
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43566055 Polyaxial Reduction Pedicle Screw, Cannulated ø=6.0 L=55
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43516050 Polyaxial Pedicle Screw ø=6.0 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43586055 Polyaxial Reduction Pedicle Screw, Cannulated ø=6.0 L=55
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41006210 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=210
FDA UDI
Class IIActive
Orthopedic Manual Surgical Instrument 75046 Pin M1.2*L121mm
FDA UDI
Class IActive
Bicera® Resorbable Bone Substitute BC-G17(1.0-2.0mm,0.5g)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43566035 Polyaxial Reduction Pedicle Screw, Cannulated ø=6.0 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40057180 Cross-Link Assembly with Anodized Hook ø=3.0 L=80
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41006040 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41000045 Rod with Taper Tips, Straight ø=5.5 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002080 Rod with Taper Tips, Pre-bent ø=5.5 L=80
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43526055 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=55
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40040070 Cross-Link Rod ø=3.0 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002070 Rod with Taper Tips, Pre-bent ø=5.5 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43556550 Polyaxial Reduction Pedicle Screw ø=6.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43536045 Polyaxial Pedicle Screw ø=6.0 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43527040 Polyaxial Pedicle Screw, Cannulated ø=7.0 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43547040 Polyaxial Pedicle Screw, Cannulated ø=7.0 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43555035 Polyaxial Pedicle Screw ø=5.0 / L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40044005 Cross-Link Nut ø=6.0 L=4.5
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43537065 Polyaxial Pedicle Screw ø=7.0 L=65
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43587535 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.5 L=35
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G18(1.0-2.0mm,1.0g)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40047060 Rod, Straight ø=5.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43546550 Polyaxial Pedicle Screw, Cannulated ø=6.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43585550 Polyaxial Reduction Pedicle Screw, Cannulated ø=5.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002090 Rod with Taper Tips, Pre-bent ø=5.5 L=90
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43566535 Polyaxial Reduction Pedicle Screw, Cannulated ø=6.5 L=35
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G16(1.0-2.0mm,0.25g)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41000060 Rod with Taper Tips, Straight ø=5.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41004280 Rod with Taper Tip and Grooved End ø=5.5 L=280
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41006035 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43526550 Polyaxial Pedicle Screw, Cannulated ø=6.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43575550 Polyaxial Reduction Pedicle Screw ø=5.5 L=50
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G26(1.0-2.0mm,30c.c.)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43547560 Polyaxial Pedicle Screw, Cannulated ø=7.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002230 Rod with Taper Tips, Pre-bent ø=5.5 L=230
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G12(0.25-0.5mm,1g)
FDA UDI
Class IIActive
Orthopedic Manual Surgical Instrument 75047 Pin M1.2*L167mm
FDA UDI
Class IActive
Wiltrom Spinal Fixation System 41000130 Rod with Taper Tips, Straight ø=5.5 L=130
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40040040 Cross-Link Rod ø=3.0 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43516045 Polyaxial Pedicle Screw ø=6.0 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43556535 Polyaxial Reduction Pedicle Screw ø=6.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43577055 Polyaxial Reduction Pedicle Screw ø=7.0 L=55
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43516535 Polyaxial Pedicle Screw ø=6.5 L=35
FDA UDI
Class IIActive

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Importers

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Notified Bodies

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Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Wiltrom Corporation Limited Zhubei City Hsinchu · TW FEI 3011964577