DEVICE: PCA Head (07613327013245)
Device Identifier (DI) Information
PCA Head
6280-0-328
In Commercial Distribution
6280-0-328
Howmedica Osteonics Corp.
6280-0-328
In Commercial Distribution
6280-0-328
Howmedica Osteonics Corp.
Femoral Head
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 |
---|---|
Metallic femoral head prosthesis | A sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
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 |
KWL | Prosthesis, hip, hemi-, femoral, metal |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Offset: 10.0 Millimeter |
Outer Diameter: 28.0 Millimeter |
Device Record Status
28a69148-0271-436a-881d-c172c796672a
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 |
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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