DEVICE: System 12 (07613153076056)
Device Identifier (DI) Information
System 12
6302-6-005
In Commercial Distribution
6302-6-005
Howmedica Osteonics Corp.
6302-6-005
In Commercial Distribution
6302-6-005
Howmedica Osteonics Corp.
Lateralizing Insert
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
44362 | Constrained polyethylene acetabular liner |
A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
KWL | Prosthesis, hip, hemi-, femoral, metal |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
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 |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
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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Lumen/Inner Diameter: 26.0 Millimeter |
Device Size Text, specify: Acetabular Insert: P5 |
Device Size Text, specify: Offset: 4.0 Millimeter |
Device Record Status
c1df654a-cc98-4229-a370-c0c6ccd6d715
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 |
---|---|
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