DEVICE: Klassic HD Acetabular Insert with XLPE (00814703015045)

Device Identifier (DI) Information

Klassic HD Acetabular Insert with XLPE
3503.44.022
In Commercial Distribution

TOTAL JOINT ORTHOPEDICS, INC.
00814703015045
GS1

1
078416717 *Terms of Use
Acetabular Insert with XLPE, 22mm head, size 44mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
43168 Non-constrained polyethylene acetabular liner
A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180929 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: The Klassic HD Hip System should be stored in a clean, dry location at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 22mm head, size 44mm
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Device Record Status

47de307b-bb6a-4879-b231-b684ae3a347b
July 13, 2018
1
June 12, 2018
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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

[?]
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
Yes
No
No CLOSE

Customer Contact

[?]
+1(801)486-6070
udi@tjoinc.com
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