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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
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
3014387294
DUNS Number
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Catalogue (561)

Page 3 of 12
DeviceModel / ReferenceRegistriesClassStatus
Wiltrom Spinal Fixation System 43587560 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41000160 Rod with Taper Tips, Straight ø=5.5 L=160
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40050170 Cross-Link Assembly ø=3.0 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43515030 Polyaxial Pedicle Screw ø=5.0 L=30
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43525545 Polyaxial Pedicle Screw, Cannulated ø=5.5 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43547545 Polyaxial Pedicle Screw, Cannulated ø=7.5 L=45
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G27(2.0-3.0mm,15c.c.)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43527560 Polyaxial Pedicle Screw, Cannulated ø=7.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002060 Rod with Taper Tips, Pre-bent ø=5.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43545535 Polyaxial Pedicle Screw, Cannulated ø=5.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43517030 Polyaxial Pedicle Screw ø=7.0 L=30
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G24(1.0-2.0mm,15c.c.)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41004110 Rod with Taper Tip and Grooved End ø=5.5 L=110
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43517555 Polyaxial Pedicle Screw ø=7.5 L=55
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43537040 Polyaxial Pedicle Screw ø=7.0 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43585035 Polyaxial Reduction Pedicle Screw, Cannulated ø=5.0 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43577045 Polyaxial Reduction Pedicle Screw ø=7.0 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41000270 Rod with Taper Tips, Straight ø=5.5 L=270
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43555550 Polyaxial Reduction Pedicle Screw ø=5.5 L=50
FDA UDI
Class IIActive
Bicera® Resorbable Bone Substitute BC-G20(2.0-3.0mm,0.25g)
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43565535 Polyaxial Reduction Pedicle Screw, Cannulated ø=5.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43546570 Polyaxial Pedicle Screw, Cannulated ø=6.5 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43556560 Polyaxial Reduction Pedicle Screw ø=6.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43536535 Polyaxial Pedicle Screw ø=6.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43536570 Polyaxial Pedicle Screw ø=6.5 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43536550 Polyaxial Pedicle Screw ø=6.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002130 Rod with Taper Tips, Pre-bent ø=5.5 L=130
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002300 Rod with Taper Tips, Pre-bent ø=5.5 L=300
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43585535 Polyaxial Reduction Pedicle Screw, Cannulated ø=5.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002170 Rod with Taper Tips, Pre-bent ø=5.5 L=170
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43566570 Polyaxial Reduction Pedicle Screw, Cannulated ø=6.5 L=70
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43567050 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.0 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43547550 Polyaxial Pedicle Screw, Cannulated ø=7.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41006260 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=260
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41006120 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=120
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43557560 Polyaxial Reduction Pedicle Screw ø=7.5 L=60
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43526045 Polyaxial Pedicle Screw, Cannulated ø=6.0 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43566545 Polyaxial Reduction Pedicle Screw, Cannulated ø=6.5 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43537535 Polyaxial Pedicle Screw ø=7.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43517040 Polyaxial Pedicle Screw ø=7.0 L=40
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41006170 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=170
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43585045 Polyaxial Reduction Pedicle Screw, Cannulated ø=5.0 L=45
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 41002180 Rod with Taper Tips, Pre-bent ø=5.5 L=180
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43517535 Polyaxial Pedicle Screw ø=7.5 L=35
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43545550 Polyaxial Pedicle Screw, Cannulated ø=5.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43515530 Polyaxial Pedicle Screw ø=5.5 L=30
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43517550 Polyaxial Pedicle Screw ø=7.5 L=50
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43527065 Polyaxial Pedicle Screw, Cannulated ø=7.0 L=65
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 40047450 Rod, Straight ø=5.5 L=450
FDA UDI
Class IIActive
Wiltrom Spinal Fixation System 43536530 Polyaxial Pedicle Screw ø=6.5 L=30
FDA UDI
Class IIActive

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Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

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

  • Wiltrom Corporation Limited Zhubei City Hsinchu · TW FEI 3011964577