DEVICE: Corin TriFit CF Hip Stem (05056139234187)

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Device Record History
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Device Identifier (DI) Information
Corin TriFit CF Hip Stem
6950000
In Commercial Distribution
6950000
CORIN LTD
05056139234187
GS1

1
295437313 *Terms of Use
TriFit CF Starter Rasp
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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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
36167 Orthopaedic broach
A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K173880 000
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
No Device Sizes
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Device Record Status
5a8235e1-943a-4fbf-8649-1b779eeedaf9
April 04, 2019
1
March 27, 2019
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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

[?]
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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