DEVICE: Definition (07613327035919)

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Device Identifier (DI) Information

Definition
6265-4-413
6265-4-413
Howmedica Osteonics Corp.
07613327035919
GS1
1
Modified Distal Centralizer
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile A sterile, non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs, e.g., straight or tapered, hollow with a fenestrated surface, and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and is not intended for spinal indication.
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FDA Product Code

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Product Code Product Code Name
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWL Prosthesis, hip, hemi-, femoral, metal
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

[?]
Size Type Text
Device Size Text, specify: Type: A
Device Size Text, specify: Diameter: 13.0 Millimeter
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Device Status

In Commercial Distribution
September 24, 2015

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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

[?]
No Customer Contact currently defined
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