DEVICE: Omnifit (07613327021813)
Device Identifier (DI) Information
Omnifit
6034-0625
In Commercial Distribution
6034-0625
Howmedica Osteonics Corp.
6034-0625
In Commercial Distribution
6034-0625
Howmedica Osteonics Corp.
Normalized Hip Stem
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 |
---|---|
Uncoated hip femur prosthesis, modular | A sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement. |
FDA Product Code
[?]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 |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Stem Length: 120.0 Millimeter |
Device Size Text, specify: Neck Length: 25.0 Millimeter |
Device Size Text, specify: Size: 6 |
Device Size Text, specify: Taper Connection: C-TPR |
Device Record Status
047c6fb7-64b0-4b0a-a6eb-53e29c3dd0d1
March 29, 2018
2
September 24, 2015
March 29, 2018
2
September 24, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined