DEVICE: INSTRUMENT (07613327012378)
Device Identifier (DI) Information
INSTRUMENT
2208-6077L
In Commercial Distribution
2208-6077L
Howmedica Osteonics Corp.
2208-6077L
In Commercial Distribution
2208-6077L
Howmedica Osteonics Corp.
RESTORATION ANATOMIC SHELL TRIAL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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 |
---|---|
Acetabulum prosthesis trial, reusable | A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED |
MEH | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate |
HWC | Screw, fixation, bone |
KWZ | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented |
LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
KWL | Prosthesis, hip, hemi-, femoral, metal |
MAY | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish |
MBL | Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous |
JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
LWJ | Prosthesis, hip, semi-constrained, metal/polymer, uncemented |
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 |
---|
Outer Diameter: 77.0 Millimeter |
Device Size Text, specify: Side: LEFT |
Device Record Status
e1a8fd33-d120-4d10-9e5e-dfbe2abdc145
February 07, 2019
4
September 24, 2016
February 07, 2019
4
September 24, 2016
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