DEVICE: GMRS (07613327033717)

Device Identifier (DI) Information

GMRS
6495-5-216
In Commercial Distribution
6495-5-216
Howmedica Osteonics Corp.
07613327033717
GS1

1
058311945 *Terms of Use
Bowed Press-Fit Stem
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Press-fit femoral stem prosthesis A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].
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FDA Product Code

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Product Code Product Code Name
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
KRO PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K022403 000
K023087 000
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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

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Size Type Text
Device Size Text, specify: Diameter: 16.0 Millimeter
Length: 150.0 Millimeter
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Device Record Status

fc421932-ccb3-4906-a75b-a939453faa7d
July 06, 2018
3
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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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