DEVICE: INSTRUMENT (07613327221367)
Device Identifier (DI) Information
INSTRUMENT
6278-9-010
In Commercial Distribution
6278-9-010
Howmedica Osteonics Corp.
6278-9-010
In Commercial Distribution
6278-9-010
Howmedica Osteonics Corp.
RESTORATION MODULAR INST SYS STRAIGHT DISTAL STEM TRIAL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Femoral stem trial prosthesis | A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set of trial hip prostheses that match the different anatomical structures of the hip joint, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems and trial necks. This is a reusable device intended to be sterilized prior to use. |
FDA Product Code
[?]Product Code | Product Code Name |
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LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Diameter: 10.0 Millimeter |
Length: 127.0 Millimeter |
Device Record Status
d922cc50-bcd6-4e5d-b860-c0934734cd0e
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined