DEVICE: INSTRUMENT (07613327180213)

Device Identifier (DI) Information

INSTRUMENT
1100-1335S
In Commercial Distribution
1100-1335S
Howmedica Osteonics Corp.
07613327180213
GS1

1
058311945 *Terms of Use
CUTTING EDGE ADVANTAGE / SECUR-FIT MAX DEGREE TRIAL NECK
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58481 Femoral stem prosthesis trial
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, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
HWC Screw, fixation, bone
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
KWL Prosthesis, hip, hemi-, femoral, metal
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
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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: Taper Connection: C-TPR
Length: 35.0 Millimeter
Device Size Text, specify: Degree: 132.0 Degree
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Device Record Status

370a7c7c-e608-4e5f-b93f-11e9419619ed
September 18, 2023
5
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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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