DEVICE: Xcaliber Bone Screws (18054242512097)

Device Identifier (DI) Information

Xcaliber Bone Screws
1
In Commercial Distribution
99-944430
ORTHOFIX SRL
18054242512097
GS1

1
438793622 *Terms of Use
SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D.6MM THREAD 4MM 120/30 QC STERILE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

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?
32854 Orthopaedic bone pin, non-bioabsorbable
A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
JDW Pin, Fixation, Threaded
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K955848 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: THREAD LENGHT 30 MM
Length: 120 Millimeter
Device Size Text, specify: THREAD MAJOR DIAMETER 4 MM
Outer Diameter: 6 Millimeter
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Device Record Status

5f354032-d375-46c4-948a-9c4d2dbe69de
July 14, 2025
6
September 01, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+039456719000
info@orthofix.it
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