DEVICE: U1 Hip System, Bipolar Cup Liner (04711605564915)

Device Identifier (DI) Information

U1 Hip System, Bipolar Cup Liner
1601-1060
In Commercial Distribution
1601-1060
UNITED ORTHOPEDIC CORP.
04711605564915
GS1

1
656700556 *Terms of Use
U1 Bipolar cap liner,60mm
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Femoral head bipolar component A sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.
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FDA Product Code

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Product Code Product Code Name
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K050269 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 60 Millimeter
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Device Record Status

3adab1cd-5580-4ed9-abd6-d366bfdf84f1
August 02, 2018
4
October 24, 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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+886229294567
service@uoc.com.tw
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