DEVICE: TriFit TS Blade Stem (05055343885451)

Device Identifier (DI) Information

TriFit TS Blade Stem
695.571
In Commercial Distribution
695.571
CORIN LTD
05055343885451
GS1

1
295437313 *Terms of Use
NECK TRIAL - LATERALISED
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
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, 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.
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FDA Product Code

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Product Code Product Code Name
KWL Prosthesis, hip, hemi-, femoral, metal
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121563 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
No Device Sizes
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Device Record Status

c30ab3ca-de85-4874-b8e5-a3cea5e82568
July 06, 2018
4
August 17, 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

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+441285659866 2203
lucinda.gerber@coringroup.com
+441285659866 2118
rachel.king@coringroup.com
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