DEVICE: Wiltrom Spinal Fixation System (04719873027378)
Device Identifier (DI) Information
Wiltrom Spinal Fixation System
40044005 Cross-Link Nut ø=6.0 L=4.5
In Commercial Distribution
WILTROM CO., LTD.
40044005 Cross-Link Nut ø=6.0 L=4.5
In Commercial Distribution
WILTROM CO., LTD.
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that
allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal
Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are
made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile,
and the implants are for single use only.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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66947 | Orthopaedic bone screw (non-sliding) |
A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.
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FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKB | Thoracolumbosacral Pedicle Screw System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K202894 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 23 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f974cced-3a0e-456a-b30d-8e20c5a8e844
February 06, 2025
3
November 17, 2022
February 06, 2025
3
November 17, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+88636107168
service@wiltrom.com.tw
service@wiltrom.com.tw