DEVICE: PROFEMUR® (M684PHAC12121)
Device Identifier (DI) Information
PROFEMUR®
PHAC1212
In Commercial Distribution
PHAC1212
Microport Orthopedics Inc.
PHAC1212
In Commercial Distribution
PHAC1212
Microport Orthopedics Inc.
PROFEMUR® NECK A/R VAR/VAL 2 SHORT COBALT CHROME
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
59688 | Femoral head/stem prosthesis adaptor |
A sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented |
LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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 |
---|
No Device Sizes |
Device Record Status
cba4bab7-fd48-4ac1-9a06-d2f3fc17683f
March 29, 2018
2
October 20, 2015
March 29, 2018
2
October 20, 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
[?]
1-866-872-0211
customerservice2@ortho.microport.com
customerservice2@ortho.microport.com