DEVICE: OrthoMedFlex (M7161111813010)

Device Identifier (DI) Information

OrthoMedFlex
111-18-1301
In Commercial Distribution
111-18-1301
ORTHOMEDFLEX LLC
M7161111813010
HIBCC

1
034442726 *Terms of Use
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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?
38155 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].
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
No Device Sizes
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Device Record Status

cd791f1b-5e3f-4d4a-92fe-b6deacf5b01a
March 29, 2018
2
April 08, 2016
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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
Yes
No CLOSE

Customer Contact

[?]
1-844-663-3539
info@orthomedflex.com
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