DEVICE: INSTRUMENT (07613327214833)

Device Identifier (DI) Information

INSTRUMENT
2240-22E
In Commercial Distribution
2240-22E
Howmedica Osteonics Corp.
07613327214833
GS1

1
058311945 *Terms of Use
TRIDENT ECCENTRIC INSERT TRIALS
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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
Acetabulum trial prosthesis, reusable A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
HWC Screw, fixation, bone
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWL Prosthesis, hip, hemi-, femoral, metal
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Degree: 0.0 Degree
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Device Record Status

85f647c4-b6c2-413e-83d1-e9a31f277057
July 06, 2018
3
September 24, 2016
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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