DEVICE: ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS (05055662934786)

Device Identifier (DI) Information

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS
OS323011
In Commercial Distribution
OS323011
ORTHO SOLUTIONS HOLDINGS LIMITED
05055662934786
GS1

1
218648211 *Terms of Use
5.0MM CANN. SCREW PIN 2.0MM X 9 inches BAYONET TIP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a 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 material that is not chemically degraded or absorbed by natural body processes (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
HWC Screw, Fixation, Bone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110895 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

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Size Type Text
No Device Sizes
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Device Record Status

75a849ea-c4f2-48a0-bda6-fed786c1e84c
September 18, 2023
4
March 08, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05055662934779 10 05055662934786 In Commercial Distribution Cardboard Box
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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

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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
No
Yes
No
No CLOSE

Customer Contact

[?]
+441621843599
quality@orthosol.com
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