DEVICE: U2 Hip Stem, Revision Hip Stem Collarless, Curved (04712602340694)

Device Identifier (DI) Information

U2 Hip Stem, Revision Hip Stem Collarless, Curved
1104-1716
In Commercial Distribution
1104-1716
UNITED ORTHOPEDIC CORP.
04712602340694
GS1

1
656700556 *Terms of Use
No description.
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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
Metal-on-polyethylene total hip prosthesis A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.
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FDA Product Code

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Product Code Product Code Name
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062978 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
Device Size Text, specify: 16.5mm, L
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Device Record Status

de83f93e-95da-4b09-8636-865e4568f471
July 06, 2018
3
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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No Customer Contact currently defined
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