DEVICE: INSTRUMENT (07613327188691)
Device Identifier (DI) Information
INSTRUMENT
6364-8-032
In Commercial Distribution
6364-8-032
Howmedica Osteonics Corp.
6364-8-032
In Commercial Distribution
6364-8-032
Howmedica Osteonics Corp.
EXETER TRIAL HEAD FOR RASP
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Femoral head trial prosthesis | A copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set of hip trial prostheses that match the different anatomical structures of the hip joint, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. 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: Offset: -4.0 Millimeter |
Device Size Text, specify: Taper Connection: V40? |
Device Size Text, specify: Head Diameter: 32.0 Millimeter |
Device Record Status
f5bfc19b-c877-4142-b072-2bd0c5224a32
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