DEVICE: System 12 (07613327139006)

Device Identifier (DI) Information

System 12
6302-H-928
In Commercial Distribution
6302-H-928
Howmedica Osteonics Corp.
07613327139006
GS1

1
058311945 *Terms of Use
Constrained Acetabular Insert
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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. 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?
44362 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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K063550 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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: Offset: 4.0 Millimeter
Lumen/Inner Diameter: 28.0 Millimeter
Device Size Text, specify: Acetabular Insert: P9
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Device Record Status

abf5f5b4-8b18-403f-a03f-61e0b25371c7
July 06, 2018
3
September 24, 2015
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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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